K260695
- 510(k) number
- K260695
- Device name
- da Vinci Firefly Imaging System
- Applicant
- Intuitive Surgical CA · US
- Product code
- NAY — System, Surgical, Computer Controlled Instrument
- Decision date
- 2026-05-22
- Date received
- 2026-03-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K260695.pdf
Official FDA record: K260695
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.