Instrument Exit Point on Touch Surgery Aide is an AI-enabled medical device from Covidien, LLC that the U.S. FDA cleared through 510(k) K253984 on June 4, 2026. Its lead review panel is Gastroenterology-Urology and its primary product code is SFE (Endoscopic Video Imaging System / Software Component For Real Time Video Augmentation).
See also all FDA AI clearances in 2026, top gastroenterology-urology AI devices.
Key facts
| Submission number | K253984 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | Covidien, LLC |
| Lead review panel | Gastroenterology-Urology |
| Primary product code | SFE — Endoscopic Video Imaging System / Software Component For Real Time Video Augmentation |
| Applicant (openFDA) | Covidien, LLC |
| Applicant location | Mansfield, MA, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 876.1500 |
| Decision code | SESE |
| Submission type | Traditional |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. Instrument Exit Point on Touch Surgery Aide went through this pathway (K253984).
openFDA lists it as a Class 2 device under 21 CFR 876.1500. Class II devices are moderate risk and are subject to general and special controls.
Product code SFE covers 2 devices on the FDA AI list. By decision date, this device is #2 of 2 under that code. Covidien, LLC has 2 AI-enabled devices on the list, and the Gastroenterology-Urology panel accounts for 27 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.