da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K213710 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 Fluorescence Imaging Vision System, also known as the da Vinci Firefly Imaging System, is a computer-controlled surgical instrument. It is designed to provide real-time endoscopic visible and near-infrared fluorescence imaging to assist surgeons during minimally invasive procedures.
This system enables the visual assessment of vessels, blood flow, tissue perfusion, and bile ducts. It has received FDA 510(k) clearance for use in gastroenterology and urology applications.
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, PDF Fluorescence imaging for da Vinci X and da Vinci Xi surgical systems, Multi-wavelength fluorescence imaging with a da Vinci Firefly—a ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K213710 | Class II | Active |
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Manufacturer
- Manufacturer
- Intuitive Surgical, Inc.
Sources (1)
- FDA 510(k) K213710 24 fields · synced Sep 25, 2026