Disclosures
Da Vinci 5 Surgical System
The da Vinci 5 Surgical System is intended to assist in the accurate control of da Vinci endoscopes and instruments during minimally invasive endoscopic urologic surgical procedures, gynecologic surgical procedures, general laparoscopic surgical procedures and thoracoscopic surgical procedures in adult and pediatric use.
It is intended for use in thoracoscopically-assisted cardiotomy procedures and minimally invasive coronary artery bypass procedures in adults. It should not be used in patients undergoing totally endoscopic coronary artery bypass, venous graft coronary bypass, or heart transplant procedures.
It is intended to be used by trained physicians in an operating room environment.
The da Vinci 5 Surgical System is a class IIb medical device 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.
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 Regulation (EU 2017/745), 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 device 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.
SP SureForm 45 staplers and reloads
The SP SureForm 45 Stapler, SP SureForm 45 Curved-Tip Stapler, and SureForm 45 Reloads are intended to be used with the da Vinci SP System for resection, transection, and/or creation of anastomoses.
The SP SureForm Stapler 45, SP SureForm 45 Curved-Tip Stapler, and SP SureForm 45 Reloads are class IIa and 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.
8 mm SureForm 30 Stapler Curved-Tip
The Intuitive Surgical 8 mm SureForm 30 Curved-Tip Stapler and 8 mm SureForm 30 Reloads and accessories are intended to be used with a compatible da Vinci Surgical System for resection, transection of vasculature and tissue, and/or creation of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric Surgery.
The Intuitive Surgical 8 mm SureForm 30 Curved-Tip Stapler and 8 mm SureForm 30 Reloads and accessories are class IIa and 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.
Force Feedback Instruments
Force Feedback Instruments are intended to be used with a compatible da Vinci system for endoscopic manipulation of tissue including dissection, grasping and retraction, while being able to deliver bipolar energy, handling and driving needles and handling, tying, and cutting suture.
Force Feedback Instruments are class IIa and 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.
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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