Da Vinci X & Xi Surgical Systems
The Intuitive Surgical Endoscopic Instrument Control Systems (da Vinci X and da Vinci Xi Surgical Systems) are intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures, and trans-oral otolaryngology surgical procedures restricted to benign tumors and malignant tumors classified as T1 and T2, and for benign base of tongue resection procedures. The systems are indicated for adult and pediatric use (except for trans-oral otolaryngology surgical procedures). They are intended to be used by trained physicians in an operating room environment.
The da Vinci X and da Vinci Xi Surgical Systems are class IIb medical devices CE marked (CE 2460) under the European Medical Devices Directive (93/42/EEC), manufactured by Intuitive Surgical, Inc. Refer to Instructions For Use before use.
Da Vinci SP Surgical System
The da Vinci SP Surgical System is intended to assist in the accurate control of the da Vinci SP endoscope and instruments during minimally invasive endoscopic abdominopelvic, thoracoscopic, transoral otolaryngology, transanal colorectal, and breast surgical procedures. The system is indicated for adult use. It is intended to be used by trained physicians in an operating room environment.
The da Vinci SP Surgical System is a class IIb medical devices CE marked (CE 2460) under the European Medical Devices Regulation (EU 2017/745), manufactured by Intuitive Surgical, Inc. Refer to Instructions For Use before use.
Ion Endoluminal System
The Ion Endoluminal System assists the user in navigating a catheter and endoscopic tools in the pulmonary tract using endoscopic visualization of the tracheobronchial tree for diagnostic and therapeutic procedures. The Ion Endoluminal System enables fiducial marker placement. It does not make a diagnosis and is not for pediatric use.
The Flexision Biopsy Needle is used with the Ion Endoluminal System to biopsy tissue from a target area in the lung.
The PlanPoint Software uses patient CT scans to create a 3D plan of the lung and navigation pathways for use with the Ion Endoluminal System. The Ion Endoluminal System, the Flexision Biopsy Needle and the PlanPoint Software are class IIa medical devices CE marked (CE 2460) under the European Medical Devices Regulation (EU 2017/745), manufactured by Intuitive Surgical, Inc. Refer to Instructions For Use before use.
SynchroSeal
SynchroSeal is a bipolar electrosurgical instrument for use with a compatible da Vinci Surgical System and a compatible electrosurgical generator. It is intended for grasping, dissection, sealing and transection of tissue. SynchroSeal can be used to seal vessels up to and including 5 mm in diameter and tissue bundles that fit in the jaws of the instrument. SynchroSeal has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.
The SynchroSeal is a class IIb medical devices CE marked (CE 2460) under the European Medical Devices Directive (93/42/EEC), manufactured by Intuitive Surgical, Inc. Refer to Instructions For Use before use.
Vessel Sealer Extend
The Vessel Sealer Extend is a bipolar electrosurgical sealing and cutting instrument for use with the da Vinci Xi and da Vinci X Surgical Systems and the compatible electrosurgical generator. It is intended for grasping and blunt dissection of tissue and for bipolar coagulation and mechanical transection of vessels up to 7 mm in diameter and tissue bundles that fit in the jaws of the instrument. The Vessel Sealer Extend has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.
The Vessel Sealer Extend is a class IIb medical device CE marked (CE 2460) under the European Medical Devices Directive (93/42/EEC), manufactured by Intuitive Surgical, Inc. Refer to Instructions For Use before use.
EndoWrist Force Bipolar
The EndoWrist Force Bipolar is intended to be used with compatible systems for endoscopic manipulation of tissue, including dissection, grasping, retraction, and bipolar coagulation of tissue.
The EndoWrist Force Bipolar is a class IIb medical device CE marked (CE 2460) under the European Medical Devices Directive (93/42/EEC) manufactured by Intuitive Surgical, Inc. Refer to Instructions For Use before use.
SureForm 45 & 60 Staplers
The SureForm 45 Stapler & SureForm 60 Stapler and SureForm 45 Stapler Reloads & SureForm 60 Stapler Reloads and other Stapler Accessories (including the bladeless obturators) are intended to be used with a compatible da Vinci Surgical System for resection, transection, and, or creation of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric surgery. The devices can be used with staple line or tissue buttressing material (natural or synthetic).
The SureForm 60 Stapler and SureForm 45 Stapler, SureForm 60 and SureForm 45 Stapler Reloads are class IIa and IIb medical devices CE marked (CE 2460) under the European Medical Devices Directive (93/42/EEC), manufactured by Intuitive Surgical, Inc. Refer to Instructions For Use before use.
Da Vinci Firefly Imaging System
The da Vinci Firefly Imaging System is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging. The da Vinci Firefly Imaging System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near infrared imaging.
Legal Notices
Individuals' outcomes may depend on a number of factors, including but not limited to patient characteristics, disease characteristics and/or physician/surgeon experience.
Some products, features or technologies may not be available in all countries. Please contact your local Intuitive representative for product availability in your region.
Refer to the product specific User Manual for indications, contraindications, warnings and other product information.
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