Instrument Exit Point on Touch Surgery Aide
Covidien, LLC is listed for Instrument Exit Point on Touch Surgery Aide (K253984). The FDA list gives June 4, 2026 as the date of the final decision. The lead panel is Gastroenterology-Urology, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code SFE as “Endoscopic Video Imaging System / Software Component For Real Time Video Augmentation”: To allow for visualization of body cavities through an endoscope with real time augmentation of video images via software to a monitor. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253984
- Date of final decision
- June 4, 2026
- Company on the FDA list
- Covidien, LLC
- Lead panel
- Gastroenterology-Urology
- Primary product code
- SFE
- openFDA device name for the code
- Endoscopic Video Imaging System / Software Component For Real Time Video Augmentation
- Device class
- 2
- Regulation number
- 876.1500
- openFDA decision description
- Substantially Equivalent
- openFDA decision code
- SESE
- Statement or summary label
- Summary
Product-code text from openFDA
To allow for visualization of body cavities through an endoscope with real time augmentation of video images via software to a monitor.