K233866
- 510(k) number
- K233866
- Device name
- Senhance Surgical System
- Applicant
- Asensus Surgical, Inc. NC · US
- Product code
- NAY — System, Surgical, Computer Controlled Instrument
- Decision date
- 2024-07-19
- Date received
- 2023-12-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.8 MB · U.S. public domain
Also available from FDA: K233866.pdf
Official FDA record: K233866
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.