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Da Vinci Surgical System and Endoscopic Instruments Modification

FDA 510(k)

Class II (US FDA 510(k))

510(k) K050802

by Intuitive Surgical, Inc.

Identifiers

510(k) Number
K050802 FDA 510(k)
FDA Product Code
NAY FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.1500 FDA 510(k)
Regulation Number
876.1500 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Da Vinci Surgical System and Endoscopic Instruments Modification is a computer-controlled surgical system designed for minimally invasive robotic-assisted procedures. It integrates robotic arms, high-definition 3D visualization, and precision endoscopic instruments to enable surgeons to perform complex surgeries with enhanced dexterity and control, primarily in gastroenterology and urology.

This modification is intended for use in operating rooms where sterile conditions are maintained. The system and instruments are reusable and require proper cleaning, disinfection, and sterilization as specified in the user manual. It is classified as a Class II medical device under FDA regulations and has received 510(k) clearance for modifications to existing endoscopic instruments and the surgical system. The system operates within MRI-safe parameters as defined by its specifications and is authorized for use in hospitals committed to minimally invasive surgical practices.

Frequently asked questions

What specialties is this Da Vinci Surgical System modification primarily intended for in clinical practice?

This modification to the Da Vinci Surgical System is primarily designed for use in gastroenterology and urology procedures, as indicated by the advisory committee classifications and medical specialty descriptions. The system’s robotic-assisted capabilities enhance precision for complex surgeries in these fields, though its broader application in minimally invasive procedures may extend to other specialties where such technology is beneficial.

Is the Da Vinci Surgical System and its endoscopic instruments reusable, and what cleaning/sterilization steps are required?

Yes, the Da Vinci Surgical System and its endoscopic instruments are reusable. They must undergo proper cleaning, disinfection, and sterilization as outlined in the manufacturer’s user manual to maintain sterile conditions during surgical use. This aligns with the system’s design for operating room environments where sterility is critical.

Can this system be used in hospitals with MRI facilities, and how does it comply with MRI safety standards?

The Da Vinci Surgical System is authorized for use in hospitals with MRI facilities, as it operates within MRI-safe parameters as defined by its specifications. However, specific MRI compatibility details (e.g., safe distances, shielding requirements) should be referenced in the system’s technical documentation or manufacturer guidelines to ensure safe coexistence with MRI equipment.

What regulatory pathway was followed for this modification, and how does it differ from the original system?

This modification received FDA 510(k) clearance under the Traditional Review pathway, demonstrating it is substantially equivalent to legally marketed predecessors. The clearance was granted for updates to the existing Da Vinci Surgical System and endoscopic instruments, not for a new indication or entirely novel technology. The advisory committee involved was the GU (Gastroenterology/Urology) Panel, reflecting the focus areas for the changes.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Intuitive introduces new enhancements for da Vinci 5 surgical ..., Da Vinci Surgical Instruments | Vision | Intuitive, Da Vinci Robotic Surgical Systems | Intuitive

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Intuitive Surgical, Inc.

Sources (1)

  • FDA 510(k) K050802 24 fields · synced Sep 19, 2026