# K260695: da Vinci Firefly Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Surgical
- Decided: May 22, 2026 after 80 days
- Product code: NAY (System, Surgical, Computer Controlled Instrument)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 26 generations back to K930667 (1994). 219 ancestors in all.
No later device cites it as a predicate yet.
6 of 220 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K251202: da Vinci Surgical System (IS5000), Intuitive Surgical, Inc. (2025) Summary page 5.
- K231854: 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM, Stryker (2023) Summary page 5.

## Indications for use
Fluorescence Imaging Vision System (Firefly Imaging System) Indications for Use: Upon intravenous administration and use of an ICG drug product consistent with its approved label, 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 extrahepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near infrared imaging. Fluorescence imaging of biliary ducts with the da Vinci Firefly Imaging System is intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization. Upon interstitial administration and use of an ICG drug product consistent with its approved label, the da Vinci Firefly Imaging System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes. Upon administration and use of pafolacianine consistent with its approved label, the da Vinci Firefly Imaging System is used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.

Source page: https://510kreport.com/device/K260695
Methodology: https://510kreport.com/methodology