K254192
- 510(k) number
- K254192
- Device name
- Senhance Ultrasonic System
- Applicant
- Asensus Surgical NC · US
- Product code
- NAY — System, Surgical, Computer Controlled Instrument
- Decision date
- 2026-05-12
- Date received
- 2025-12-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K254192.pdf
Official FDA record: K254192
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.