K251426
- 510(k) number
- K251426
- Device name
- da Vinci SP Surgical System (SP1098)
- Applicant
- Intuitive Surgical, Inc. CA · US
- Product code
- NAY — System, Surgical, Computer Controlled Instrument
- Decision date
- 2025-10-03
- Date received
- 2025-05-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K251426.pdf
Official FDA record: K251426
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.