510(k) K253984
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.