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OnSite for Da Vinci Surgical Systems

FDA 510(k)

Class II (US FDA 510(k))

510(k) K121921

by Intuitive Surgical, Inc.

Identifiers

510(k) Number
K121921 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)

OnSite for Da Vinci Surgical Systems is a computer-controlled surgical support platform designed to enable remote monitoring, diagnostics, and technical assistance for Intuitive Surgical’s da Vinci robotic surgical systems. It integrates with these systems to facilitate real-time performance tracking and issue resolution, ensuring operational reliability during surgical procedures.

Supplied as a service feature, OnSite connects the da Vinci system to Intuitive Surgical’s technical support team, allowing remote access for proactive monitoring and troubleshooting. It is not a standalone medical device but a software-enabled support solution, intended for use in clinical settings where da Vinci systems are deployed. No regulatory approvals beyond the parent system’s clearance are specified for this service component.

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 OnSite: How We Keep Da Vinci Systems Up And Running, PDF OnSite for Intuitive Services, PDF Da Vinci OnSite - Intuitive Surgical

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) K121921 24 fields · synced Sep 19, 2026