da Vinci Firefly Imaging System— 510(k) K260695
Substantially EquivalentIntuitive Surgical
FDA 510(k) clearance K260695 for da Vinci Firefly Imaging System, Substantially Equivalent on 2026-05-22. Applicant: Intuitive Surgical. Device class: 2.
Summary
Intuitive Surgical's da Vinci Firefly Imaging System is filed under NAY, computer controlled surgical instrument systems.
Class II, 21 CFR 876.1500. The General and Plastic Surgery review panel handled it as a Traditional 510(k), though the record lists Gastroenterology and Urology as the classification panel.
Intuitive filed from Sunnyvale, California. The decision came 80 calendar days after receipt (March 3 to May 22, 2026).
Clearance details
- Applicant
- Intuitive Surgical
- Product code
- Product code NAY
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
Recent devices under product code NAY
view allMore clearances from Intuitive Surgical
view allAdverse events under product code NAY
product code NAY- Death
- 433
- Injury
- 7,927
- Malfunction
- 93,790
- Other
- 19
- Total
- 102,169
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.