da Vinci Firefly Imaging System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K210918 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 Firefly Imaging System is a computer-controlled surgical vision system designed to provide real-time endoscopic visible and near-infrared fluorescence imaging. It enables surgeons to visualize blood vessels, blood flow, tissue perfusion, and at least one major bile duct during minimally invasive procedures, enhancing precision and anatomical awareness.
This system is integrated for use exclusively with the da Vinci Xi and da Vinci X Surgical Systems and is intended for sterile, single-use applications in surgical settings. It operates within Class II regulatory classification under FDA 510(k) clearance (K210918) and is authorized for use in gastroenterology and urology procedures. Storage and handling must comply with manufacturer guidelines to maintain sterility and functionality.
Frequently asked questions
What is the da Vinci Firefly Imaging System used for?
The da Vinci Firefly Imaging System is designed to enhance surgical precision by enabling real-time visualization of blood vessels, blood flow, tissue perfusion, and at least one major bile duct during minimally invasive procedures. This advanced fluorescence imaging helps surgeons improve anatomical awareness and accuracy in procedures within gastroenterology and urology.
Is the da Vinci Firefly Imaging System intended for single-use or reuse?
The da Vinci Firefly Imaging System is intended for sterile, single-use applications only. This ensures patient safety and maintains the system’s functionality, as reuse could compromise sterility and performance.
Which surgical systems is the da Vinci Firefly Imaging System compatible with?
The da Vinci Firefly Imaging System is integrated exclusively for use with the da Vinci Xi and da Vinci X Surgical Systems. It is not designed to function independently or with other surgical platforms.
How should the da Vinci Firefly Imaging System be stored to maintain sterility?
Storage and handling of the da Vinci Firefly Imaging System must strictly follow the manufacturer’s guidelines to preserve sterility and functionality. Improper storage could compromise its performance and safety for surgical use.
What regulatory pathway does the da Vinci Firefly Imaging System follow?
The da Vinci Firefly Imaging System has received FDA 510(k) clearance under the classification of Class II medical devices. It was cleared as substantially equivalent to a predicate device and is authorized for use in specific surgical procedures within gastroenterology and urology.
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, 552467-06_A Firefly User Manual P9.book - Intuitive
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K210918 | Class II | Active |
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Manufacturer
- Manufacturer
- Intuitive Surgical, Inc.
Sources (1)
- FDA 510(k) K210918 24 fields · synced Oct 1, 2026