TransEnterix Senhance Surgical System is an AI-enabled medical device from TransEnterix, Inc., listed by FDA (510(k), K180163) with a decision date of 2018-05-25. Review panel: Gastroenterology-Urology.
| FDA submission number | K180163 |
|---|---|
| Pathway | 510(k) |
| Company | TransEnterix, Inc. |
| Review panel (specialty) | Gastroenterology-Urology |
| FDA decision date | 2018-05-25 |
| Decision | Substantially Equivalent |
| Product code | NAY |
| Classification | System, Surgical, Computer Controlled Instrument |
| Device class | 2 |
| Regulation number | 876.1500 |
| Review time (calendar days) | 126 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
All Gastroenterology-Urology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.