510(k) K253984
K253984 is an FDA 510(k) premarket notification submitted by Covidien, LLC for the device "Instrument Exit Point on Touch Surgery Aide". The FDA issued a decision of Substantially Equivalent on June 4, 2026. The device falls under product code SFE (Endoscopic Video Imaging System / Software Component For Real Time Video Augmentation), a Class II device regulated under 21 CFR 876.1500. Covidien, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 4, 2026
- Date Received
- December 12, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoscopic Video Imaging System / Software Component For Real Time Video Augmentation
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- SU
- Submission Type
To allow for visualization of body cavities through an endoscope with real time augmentation of video images via software to a monitor.