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da Vinci SP Firefly Imaging System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K252350

by Intuitive Surgical, Inc.

Identifiers

510(k) Number
K252350 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 SP Firefly Imaging System is a surgical, computer-controlled instrument system. It provides real-time endoscopic visible and near-infrared fluorescence imaging to assist surgeons during procedures.

The system is used in minimally invasive surgery to visualize vessels, blood flow in tissue, and at least one of the major bile ducts around the liver after injection of indocyanine green (ICG) dye. It is supplied as a reusable system and has received FDA 510(k) clearance under k-number K252350, with product code NAY and regulation number 876.1500.

Frequently asked questions

What is the da Vinci SP Firefly Imaging System used for?

The system is used in minimally invasive surgery to visualize vessels, blood flow in tissue, and at least one of the major bile ducts around the liver after injection of indocyanine green (ICG) dye, assisting surgeons during procedures with real-time endoscopic visible and near-infrared fluorescence imaging.

How is the da Vinci SP Firefly Imaging System supplied and is it reusable?

The system is supplied as a reusable system, meaning it is designed for multiple uses after appropriate reprocessing, as stated in the device description.

What regulatory clearance does the da Vinci SP Firefly Imaging System have?

The device has received FDA 510(k) clearance under k-number K252350, with product code NAY and regulation number 876.1500, as explicitly stated in the device data.

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: Da Vinci Surgical Instruments | Vision | Intuitive, Intuitive | da Vinci Surgical Instruments | Vision | IN, PDF Fluorescence imaging for da Vinci X and da Vinci Xi surgical systems

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) K252350 24 fields · synced Sep 24, 2026