510(k) K250645
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 9, 2025
- Date Received
- March 4, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Anoscope And Accessories
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
To examine and perform procedures within the anus and rectum.