Instrument Exit Point on Touch Surgery™ Aide is an AI-enabled medical device from Covidien, LLC, listed by FDA (510(k), K253984) with a decision date of 2026-06-04. Review panel: Gastroenterology-Urology.
| FDA submission number | K253984 |
|---|---|
| Pathway | 510(k) |
| Company | Covidien, LLC |
| Review panel (specialty) | Gastroenterology-Urology |
| FDA decision date | 2026-06-04 |
| Decision | Substantially Equivalent |
| Product code | SFE |
| Classification | Endoscopic Video Imaging System / Software Component For Real Time Video Augmentation |
| Device class | 2 |
| Regulation number | 876.1500 |
| Review time (calendar days) | 174 |
| 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.