510(k) K243367
K243367 is an FDA 510(k) premarket notification submitted by Minnesota Medical Technologies for the device "Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle)". The FDA issued a decision of Substantially Equivalent on July 22, 2025. The device falls under product code PBP (Rectal Insert), a Class II device regulated under 21 CFR 876.5980.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 22, 2025
- Date Received
- October 30, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Rectal Insert
- Device Class
- Class II
- Regulation Number
- 876.5980
- Review Panel
- GU
- Submission Type
Acts as a barrier to the passage of fecal matter through the rectum.