K252350
- 510(k) number
- K252350
- Device name
- da Vinci SP Firefly Imaging System
- Applicant
- Intuitive Surgical, Inc. CA · US
- Product code
- NAY — System, Surgical, Computer Controlled Instrument
- Decision date
- 2025-08-28
- Date received
- 2025-07-29
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K252350.pdf
Official FDA record: K252350
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.