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Intuitive Surgical, Inc. Registered Devices

Listing registered devices, PMA filings, and compliance records for Intuitive Surgical, Inc..

enforcement da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15 ID: Z-2722-2026
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enforcement Da Vinci ASSY, PSS, SP1098, Part Number: 380601 ID: Z-2521-2026
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enforcement Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product Description: Preface: This report under 21 CFR 806.10 is being submitted for the dV5 system tower, as the NIR Handheld Camera or SOCK is developed and integrated as part of the dV5 system. The affected component of the dV5 system tower is the NIR handheld camera, and is supplied by Schoelly as the manufacturer. Therefore, the product description in this report references the NIR handheld camera system. Product Description: The NIR handheld camera system is compatible for use with the da Vinci 5 system to aid in surgery. The components of the NIR handheld camera system include a camera control unit and a light source, NIR handheld camera, and additional components that together, connect to the Tower of the da Vinci 5 system. When setting up the da Vinci 5 system, the image from the NIR handheld camera system is displayed on the Tower monitor. Component: Yes, the SOCK is the component and integrated into the dV5 system ID: Z-2310-2026
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enforcement Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog Number: IS4000; IS4200 Software Version: N/A Product Description: he da Vinci Xi, X Surgical systems each consist of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The PC is the operative component of the system, and its primary function is to support the instrument arms and camera arm. Each system have four Universal Surgical Manipulators (USMs) also known as arms, which allow the surgeon to control up to three instruments and an endoscope simultaneously to perform surgical tasks (e.g. cutting, suturing, tissue approximation) in a variety of procedures. As the surgeon moves the hand controls within the console, the PC moves the robotic instruments within the patient in a corresponding manner. The da Vinci system and its software are designed such that instruments motion precisely tracks the motion inputs from the hand controls during surgery. Component: The affected part based on this recall, 380647-xx, USM, is a sub component of da Vinci Surgical Instrument ID: Z-2046-2026
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enforcement Brand Name: da Vinci S, Si Tenaculum Forceps Instrument Product Name: da Vinci S, Si Tenaculum Forceps Instrument Model/Catalog Number: 420207 Software Version: N/A Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories. Please refer to attached User Manual for additional details on intended use. All da Vinci S/Si reusable instruments with jaws use mechanical tungsten cables and pulleys to transmit motion from the input discs to the housing (on the proximal chassis), through the main shaft, and the distal instrument tip (inside the patient). Component: N/A ID: Z-1700-2026
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enforcement Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: da Vinci S and Si Monopolar Curved Scissors Instrument Model/Catalog Number: 420179 Software Version: N/A Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories. Please refer to attached User Manual for additional details on intended use. All da Vinci S/Si reusable instruments with jaws use mechanical tungsten cables and pulleys to transmit motion from the input discs to the housing (on the proximal chassis), through the main shaft, and the distal instrument tip (inside the patient). Component: N/A ID: Z-1696-2026
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enforcement Brand Name: da Vinci S, Si Grasping Retractor Instrument Product Name: da Vinci S, Si Grasping Retractor Instrument Model/Catalog Number: 420278 Software Version: NA Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories. Please refer to attached User Manual for additional details on intended use. All da Vinci S/Si reusable instruments with jaws use mechanical tungsten cables and pulleys to transmit motion from the input discs to the housing (on the proximal chassis), through the main shaft, and the distal instrument tip (inside the patient). Component: NA ID: Z-1699-2026
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enforcement Brand Name: da Vinci S, Si Permanent Cautery Hook Instrument Product Name: da Vinci S, Si Permanent Cautery Hook Instrument Model/Catalog Number: 420183 Software Version: NA Product Description: EndoWrist Instruments or da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories. Please refer to attached User Manual for additional details on intended use. All da Vinci S/Si reusable instruments with jaws use mechanical tungsten cables and pulleys to transmit motion from the input discs to the housing (on the proximal chassis), through the main shaft, and the distal instrument tip (inside the patient). Component: NA ID: Z-1701-2026
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enforcement Brand Name: da Vinci S, Si Double Fenestrated Grasper Instrument Product Name: da Vinci S, Si Double Fenestrated Grasper Instrument Model/Catalog Number: 420189 Software Version: NA Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories. Please refer to attached User Manual for additional details on intended use. All da Vinci S/Si reusable instruments with jaws use mechanical tungsten cables and pulleys to transmit motion from the input discs to the housing (on the proximal chassis), through the main shaft, and the distal instrument tip (inside the patient). Component: NA ID: Z-1697-2026
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enforcement Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery. ID: Z-1428-2026
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enforcement Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical System Model/Catalog Number: IS4000; IS4200; IS5000 Software Version: N/A Product Description: The da Vinci Xi, X, and da Vinci 5 surgical systems each consist of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The PC is the operative component of the system, and its primary function is to support the instrument arms and camera arm. Each system have four Universal Surgical Manipulators (USMs) also known as arms, which allow the surgeon to control up to three instruments and an endoscope simultaneously to perform surgical tasks (e.g. cutting, suturing, tissue approximation) in a variety of procedures. As the surgeon moves the hand controls within the console, the PC moves the robotic instruments within the patient in a corresponding manner. The da Vinci system and its software are designed such that instruments motion precisely tracks the motion inputs from the hand controls during surgery. Component: The affected part based on this recall, 380647-xx, USM, is a sub component of da Vinci Surgical Instrument ID: Z-1232-2026
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enforcement da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45 ID: Z-1355-2026
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enforcement Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog Number: 490127 Software Version: N/A Product Description: The Ion Endoluminal System is a robotically assisted platform for minimally invasive peripheral lung biopsy. Ion consists of a System Cart and Controller that are used to navigate a flexible Catheter within the pulmonary tract using endoscopic visualization for diagnostic and therapeutic procedures. The Ion Fully Articulating Catheter (referred to as the Catheter) consists of the housing, sensor, input discs, shaft, tool channel, and tip. The Catheter is installed on the carriage of the arm. The Catheter is provided non-sterile and is a multi-use device. The Ion Peripheral Vision Probe (referred to as the Vision Probe or VP) is an endoscope that is compatible with, and inserted into, the Catheter tool channel. The VP provides direct visualization of the patient s airways during navigation. The VP attaches to the arm and has a collar that is rotated and then pulled to release it from the arm. The VP is provided non-sterile and is a multi-use device that can be used up to 5 times. The Vision Probe Bag (referred to as VPB) installs over the Instrument Arm for temporary storage of the VP when it is not inserted within the Catheter tool channel. The VPB is a single-use device provided sterile (folded within a pouch) by Ethylene Oxide (EO) sterilization method. Refer to HHE for additional details. Component: N/A ID: Z-1134-2026
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enforcement da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1098,Box) ID: Z-1096-2026
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enforcement da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS5000; Part Number: 380730-40 ID: Z-0964-2026
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enforcement Brand Name: Da Vinci 5 Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedals Model/Catalog Number: 380730 Software Version: N/A . Refer to HHE for additional details. Component: N/A ID: Z-1325-2025
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enforcement 8MM,HORIZON SMALL CLIP APPLIER,IS4000 REF 470401 ID: Z-0870-2025
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enforcement 8MM,LONG TIP FORCEPS,IS4000 REF 471048 ID: Z-0872-2025
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enforcement 8MM, LARGE NEEDLE DRIVER, IS4000 REF 470006 ID: Z-0849-2025
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enforcement 8MM,FORCE BIPOLAR,IS4000 REF 471405 ID: Z-0883-2025
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enforcement 8MM, POTTS SCISSORS, IS4000 REF 470001 ID: Z-0848-2025
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enforcement 8MM,MICRO BIPOLAR FORCEPS,IS4000 REF 470171 ID: Z-0855-2025
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enforcement 8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 REF 470296 ID: Z-0864-2025
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enforcement 8MM,MEGA SUTURECUT ND,IS4000 REF 470309 ID: Z-0865-2025
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enforcement 8MM, Tenaculum Forceps REF 470207 Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of procedures to perform a variety of surgical tasks including manipulation and retraction of tissue. ID: Z-0923-2025
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enforcement 8MM,CURVED BIPOLAR DISSECTOR,IS4000 REF 471344 ID: Z-0881-2025
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enforcement 8MM,PROGRASP FORCEPS,IS4000 REF 470093 ID: Z-0854-2025
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enforcement 8MM, MONOPOLAR CURVED SCISSORS, IS4000 REF 470179 ID: Z-0847-2025
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enforcement 8MM,DEBAKEY FORCEPS,IS4000 REF 470036 ID: Z-0852-2025
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enforcement 8MM,MICRO BIPOLAR FORCEPS,IS4000 REF 471171 ID: Z-0875-2025
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enforcement 8MM, ROUND TIP SCISSORS, IS4000 REF 470007 ID: Z-0850-2025
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enforcement 8MM,CADIERE FORCEPS,IS4000 REF 470049 ID: Z-0853-2025
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enforcement 8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 REF 471296 ID: Z-0879-2025
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enforcement 8MM,MEGA SUTURECUT ND,IS4000 REF 471309 ID: Z-0880-2025
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enforcement 8MM,FORCE BIPOLAR,IS4000 REF 470405 ID: Z-0871-2025
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enforcement 8MM,PROGRASP FORCEPS,IS4000 REF 471093 ID: Z-0874-2025
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enforcement 8MM,TENACULUM FORCEPS,IS4000 REF 470207 ID: Z-0860-2025
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enforcement 8MM,ATRIAL RETRACTOR SHORT RIGHT,IS4000 REF 470246 ID: Z-0862-2025
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enforcement 8MM,FENESTRATED BIPOLAR FORCEPS,IS4000 REF 470205 ID: Z-0859-2025
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enforcement 8MM, Small Graptor REF 470318 Is a grasping retractor Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of procedures to perform a variety of surgical tasks including manipulation and retraction of tissue. ID: Z-0924-2025
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enforcement 8MM,LARGE HEM-O-LOK CLIP APPLIER,IS4000 REF 470230 ID: Z-0861-2025
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enforcement 8MM,MARYLAND BIPOLAR FORCEPS,IS4000 REF 470172 ID: Z-0856-2025
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enforcement 8MM,CURVED BIPOLAR DISSECTOR,IS4000 REF 470344 ID: Z-0868-2025
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enforcement 8MM,BLACK DIAMOND MICRO FORCEPS,IS4000 REF 470033 ID: Z-0851-2025
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enforcement 8MM,TIP-UP FENESTRATED GRASPER,IS4000 REF 470347 ID: Z-0869-2025
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enforcement 8MM,LONG BIPOLAR GRASPER,IS4000 REF 471400 ID: Z-0882-2025
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enforcement 8MM,FENESTRATED BIPOLAR FORCEPS,IS4000 REF 471205 ID: Z-0878-2025
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enforcement 8MM,CADIERE FORCEPS,IS4000 REF 471049 ID: Z-0873-2025
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enforcement 8MM,COBRA GRASPER,IS4000 REF 471190 ID: Z-0877-2025
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enforcement 8MM,DUAL BLADE RETRACTOR,IS4000 REF 470249 ID: Z-0863-2025
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enforcement 8MM,RESANO FORCEPS,IS4000 REF 470181 ID: Z-0857-2025
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enforcement 8MM,MEGA NEEDLE DRIVER,IS4000 REF 470194 ID: Z-0858-2025
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enforcement 8MM,MARYLAND BIPOLAR FORCEPS,IS4000 REF 471172 ID: Z-0876-2025
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enforcement 8MM,MEDIUM-LARGE CLIP APPLIER,IS4000 REF 470327 ID: Z-0867-2025
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enforcement 8MM,SMALL GRASPING RETRACTOR,IS4000 REF 470318 ID: Z-0866-2025
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enforcement Ion Endoluminal System, REF: 380748-65 ID: Z-2720-2024
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enforcement Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm ID: Z-0406-2024
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enforcement INTUITIVE Da Vinci Xi 8mm SureForm 30 Curved-Tip Stapler Da Vinci Xi|X REF 488530 INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm Gray 4-Row 2.0 mm Xi|X REF 48230M INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm White 4-Row 2.5 mm Xi|X REF 48230W INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm Blue 4-Row 3.5 mm Xi|X REF 48230B ID: Z-0340-2023
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enforcement Da Vinci S/Si Large Clip Applier, Model 420230 Da Vinci S/Si Medium-Large Clip Applier, Model 420327 Da Vinci S/Si Small Clip Applier, Model 420003 ID: Z-1459-2022
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enforcement Da Vinci X/Xi Large Clip Applier, Model 470230 Da Vinci X/Xi Medium-Large Clip Applier, Model 470327 Da Vinci X/Xi Small Clip Applier, Model 47401 ID: Z-1460-2022
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enforcement da Vinci SP Surgical systems with the following Model Name/ Model Number / UDI: ASSY,PSS,SP1098,P4/ 380601-44/ 00886874114605 ASSY,SSC,SP1098,P4/ 380940-44 / 00886874114735 ASSY,VSS,SP1098,P4/ 380941-44 / 00886874114742 SOFTWARE, SYSTEM EMBEDDED RLS, SP1098, B70_P4_B327 (OS4 v4.0.0 (P4_B327) / 610112-327 / N/A ID: Z-0419-2022
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enforcement EndoWrist Suction Irrigator, Single Use Instrument. Part Number: 480299-04. An accessory to the EndoWrist Surgical System, used in endoscopic surgery. ID: Z-0249-2020
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enforcement da Vinci Xi EndoWrist Stapler 45 Reload Green, Model 48445G-03, 12 reloads/box. ID: Z-2381-2018
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enforcement Natural Rubber Latex QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System . Intuitive Surgical Endoscopic Instrument Control System. ID: Z-1975-2014
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enforcement da Vinci Xi EndoWrist Stapler 45 Reload Blue, Model 48645B-03, 12 reloads/box. ID: Z-2380-2018
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enforcement STAPLER 30, IS4000, model number 470430; Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device is indicated for adult and pediatric use. The device can be used with staple line or tissue buttressing material. ID: Z-2349-2016
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enforcement System Manual for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System. ID: Z-1964-2014
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enforcement daVinci Harmonic ACE Curved Shears ID: Z-0841-2019
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enforcement The da Vinci Xi Surgical System (IS4000) Model Name: IS4000, Endoscope Controller. Model Number: 372601-16. ID: Z-2835-2018
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enforcement Single Site US Manuals and Single Site OUS Manuals for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System. ID: Z-1971-2014
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enforcement Vision Troubleshooting Guide for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System. ID: Z-1966-2014
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enforcement Insert for IRK for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System. ID: Z-1967-2014
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enforcement Stapler Addendum for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System. ID: Z-1968-2014
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enforcement CURVED-TIP STAPLER 30,IS4000, model number 470530; Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device is indicated for adult and pediatric use. The device can be used with staple line or tissue buttressing material. ID: Z-2350-2016
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enforcement STAPLER 45, IS4000, model number 470298 Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device can be used with staple line or tissue butressing material (natural or synthetic). ID: Z-2348-2016
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enforcement ION Reprocessing Accessories Kit, IF1000 (Part Number: 490024-03) UDI:00886874119129. The kit includes an ION Catheter Reprocessing Cover (Part Number: 490114-02). ID: Z-2950-2020
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enforcement Ion Catheter Reprocessing Cover, IF1000 (Part Number:490114-02) UDI:00886874116845. ID: Z-2949-2020
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enforcement da Vinci Xi Surgical System, IS4000; ASSY,USM,IS4000, Material number: 380647-20 and 380647-22 The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endocopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endscopic retractors, electrocautery and accessories for edoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximations, ligation, electrocautery, suturing and delivery and placement of microware and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic labaroscopic surgical procedures, general thorascopic surgical procedures and thorascopically-assisted cardiotomy procedures. ID: Z-1304-2015
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enforcement Fluorescence Imaging Procedure Kits used with the da Vinci Si and Xi Surgical Systems; Model numbers: 950156-01, 950156-02, 950156-03. Product Usage: General and plastic surgery: The da Vinci Firefly Imaging system is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging. ID: Z-2782-2015
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enforcement INSTRUMENT ARM DRAPE, IS4000, 20 PACK; used on the da Vinci Xi Surgical System. The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. ID: Z-1949-2015
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enforcement Fluorescence Imaging Procedure Kit, designed for use with Firefly Fluorescence Imaging for the da Vinci Xi 4000 Surgical Systems. The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Surgical da Vinci Surgical System Model IS3000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. ID: Z-0835-2015
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enforcement Connection QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System . Intuitive Surgical Endoscopic Instrument Control System. ID: Z-1974-2014
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enforcement IRK QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System and Si-e. Intuitive Surgical Endoscopic Instrument Control System. ID: Z-1972-2014
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enforcement da Vinci Xi Surgical System, IS4000; Assy, Distal SUJ, Inner, IS4000 Material number: 380662-20 and 380662-21. The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endocopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endscopic retractors, electrocautery and accessories for edoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximations, ligation, electrocautery, suturing and delivery and placement of microware and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic labaroscopic surgical procedures, general thorascopic surgical procedures and thorascopically-assisted cardiotomy procedures. ID: Z-1302-2015
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enforcement da Vinci Xi" Surgical System, model number IS4000, A70_P5x with P5 Software; General and Plastic Surgery: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximations, ligation, electrocautery, suturing and delivery and placement of microware and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. ID: Z-0315-2017
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enforcement Vessel Sealer QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System. ID: Z-1970-2014
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enforcement Cautery QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System . Intuitive Surgical Endoscopic Instrument Control System. ID: Z-1973-2014
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enforcement Endowrist Instrument and Accessory Manual for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System. ID: Z-1965-2014
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enforcement Vessel Sealer Addendum for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System. ID: Z-1969-2014
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enforcement Patient Side Cart assembly, 4-arm, for use with Intuitive Surgical, Inc. da Vinci Surgical System IS 4000. The patient-side cart is positioned at the operating room table and contains four arms that are positioned over the target patient anatomy. The endoscope attaches onto any arm. The patient-side assistant attaches/detaches the endoscope and instrument intra-operatively. ID: Z-1718-2014
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enforcement Thoracic Grasper, 5 MM, for use with da Vinci S (IS2000) and SI (IS3000) Surgical Systems. Intended for endoscopic manipulation of tissue, including grasping. ID: Z-1812-2015
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enforcement Fluorescence Imaging Procedure Kit, designed for use with Firefly Fluorescence Imaging for the da Vinci Si 3000 Surgical Systems. The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Surgical da Vinci Surgical System Model IS3000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. ID: Z-0834-2015
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enforcement da Vinci X Surgical System, Model IS4200. Product Usage: The Intuitive Surgical Endoscopic Instrument Control System (da Vinci X Surgical System Mode IS4200) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use. ID: Z-2341-2018
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enforcement da Vinci Xi Surgical System, IS4000; ASSY,DISTAL SUJ,OUTER,IS4000, Material number: 380663-20 and 380663-21. The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endocopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endscopic retractors, electrocautery and accessories for edoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximations, ligation, electrocautery, suturing and delivery and placement of microware and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic labaroscopic surgical procedures, general thorascopic surgical procedures and thorascopically-assisted cardiotomy procedures. ID: Z-1303-2015
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enforcement da Vinci Xi and X 12-8 mm Conductive Cannula Reducer, REF: 470381-11 ID: Z-0702-2022
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enforcement The da Vinci Xi and X surgical systems (IS4000 and IS4200) each consist of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The Patient Cart is the operative component of the system and its primary function is to support the instrument arms and camera arm. The X/Xi Instrument Arm Drape is intended to be used with the instrument arms of the PC as a sterile barrier during clinical procedures, and makes the instrument arms sterile and suitable for surgery. X/Xi Instrument Arm Drapes are sterile unless the package is opened or damaged, and are indicated for a single use. The drapes are placed onto the instrument arms by two users (one sterile and one non-sterile)in tandem, with the non-sterile user leading the placement via drape cuff pockets. ID: Z-0275-2022
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enforcement da Vinci Si/X/Xi Surgical System Redundant Medical Grade Power Supply (RMGPS) Units The da Vinci System consists of a Surgeon Console, a Patient Cart, and a Vision Cart and is used with an endoscope, da Vinci EndoWrist instruments, and accessories to perform minimally invasive surgery. All three components must be powered on for the system to be functional. ID: Z-3254-2018
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enforcement Patient Side Cart Battery Box used in conjunction with the da Vinci A surgical system. Intuitive Surgical Inc. Sunnyvale, CA 94086 ID: Z-1994-2014
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enforcement Intuitive Surgical Inc. Large Clip Applier instruments used in conjunction with da Vinci S and da Vinci SI Surgical Systems Intuitive Surgical Inc., 'Sunnyvale, CA 94086 ID: Z-2020-2014
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enforcement Tip Cover for 8mm Monopolar Curved Scissors (Hot Shears)Accessory, Disposable, 8mm MCS, Box of 10. The intended use of the Tip Cover Accessory is to provide dielectric insulation over a section of the Monopolar Curved Scissor instrument so that RF energy is only available at the scissor blades. The Monopolar Curved Scissors are intended for endoscopic manipulation of tissue, including: cutting, blunt and sharp dissection, electrocautery. This accessory is to be used with the Intuitive Surgical Endoscopic Instrument Control Systems (da Vinci, da Vinci S and da Vinci Si Surgical Systems Models IS1200, 12000, ISSOQO). ID: Z-2339-2012
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