510(k) K182421 ยท NAY System, Surgical, Computer Controlled Instrument
Senhance Ultrasonic System
| Applicant | Transenterix, Inc., Morrisville NC, US |
| Decision | Substantially Equivalent, Jan 11, 2019 |
| Received | Sep 5, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182421
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.