K243714
- 510(k) number
- K243714
- Device name
- da Vinci SP Surgical System (SP1098)
- Applicant
- Intuitive Surgical, Inc. CA · US
- Product code
- NAY — System, Surgical, Computer Controlled Instrument
- Decision date
- 2025-04-24
- Date received
- 2024-12-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.5 MB · U.S. public domain
Also available from FDA: K243714.pdf
Official FDA record: K243714
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.