We are pleased to announce that the US Food and Drug Administration (FDA) provided 510(k) clearance for the da Vinci 5, Intuitive’s next generation multiport robotic system. We will prepare to expand the rollout of the da Vinci 5 Surgical System in Europe based on in-country regulatory requirements to ensure the highest level of quality and safety.
The da Vinci 5 is not CE Marked and cannot be placed on the market nor put into service.
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.
Da Vinci X & Xi Surgical Systems
Medical devices, CE 2460, refer to Instructions For Use for further information.
Da Vinci SP Surgical System
Medical device, CE 2460, refer to Instructions For Use for further information.
Da Vinci 5
The da Vinci 5 is not CE Marked and cannot be placed on the market nor put into service.
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.
Da Vinci Table Motion
The da Vinci Table Motion is intended to allow the surgical staff to reposition the patient by adjusting the table without undocking the da Vinci Xi Surgical System during urologic surgical procedures, general laparoscopic surgical procedures, and gynecologic surgical procedures. It is designed to be used with a compatible operating room (OR) table.
EndoWrist Instruments
Medical devices, CE 2460, refer to Instructions For Use for further information.
Vessel Sealer Extend
Medical device, CE 2460, refer to Instructions For Use for further information.
Endoscope
Medical device, CE 2460, refer to Instructions For Use for further information.