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da Vinci Handheld Camera

FDA 510(k)

Class II (US FDA 510(k))

510(k) K191043

by Intuitive Surgical, Inc.

Identifiers

510(k) Number
K191043 FDA 510(k)
FDA Product Code
GCJ 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 Handheld Camera is a class I medical device intended for endoscopic viewing of internal surgery sites during minimally invasive surgery. It is designed for use with compatible da Vinci Surgical Systems and is part of the da Vinci Vision system.

The device is supplied as a reusable endoscopic camera and is compatible with da Vinci X and da Vinci Xi surgical systems. It is manufactured by Intuitive Surgical, Inc. and has received FDA 510(k) clearance under k-number K191043 with product code GCJ.

Frequently asked questions

What is the da Vinci Handheld Camera used for?

The da Vinci Handheld Camera is intended for endoscopic viewing of internal surgery sites during minimally invasive surgery, providing visual guidance to surgeons during procedures when used with compatible da Vinci Surgical Systems.

Is the da Vinci Handheld Camera reusable or single-use?

The da Vinci Handheld Camera is supplied as a reusable endoscopic camera, meaning it can be cleaned, sterilized, and used multiple times in accordance with the manufacturer's reprocessing instructions.

Which da Vinci Surgical Systems is the Handheld Camera compatible with?

The da Vinci Handheld Camera is designed for use with compatible da Vinci X and da Vinci Xi surgical systems, forming part of the da Vinci Vision system for integrated endoscopic imaging during surgery.

What regulatory clearance does the da Vinci Handheld Camera have?

The da Vinci Handheld Camera has received FDA 510(k) clearance under k-number K191043 with product code GCJ, indicating it was found substantially equivalent to a legally marketed predicate device.

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: PDF Da Vinci Handheld Camera - intuitive.com, Intuitive | da Vinci Surgical Instruments | Vision | UK, PDF Handheld Camera - Cordamed, DaVinci X and Da Vinci Xi Handheld Camera from DaVinci Vision VER 2 ...

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) K191043 24 fields · synced Sep 22, 2026