510(k) K254192 ยท NAY System, Surgical, Computer Controlled Instrument
Senhance Ultrasonic System
| Applicant | Asensus Surgical, Durham NC, US |
| Decision | Substantially Equivalent, May 12, 2026 |
| Received | Dec 23, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254192
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.