PBP
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Rectal Insert
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5980
- Medical specialty
- Gastroenterology, Urology
- Flags
- Third-party review eligible
- FDA definition
- Acts as a barrier to the passage of fecal matter through the rectum.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle) (K243367) | Minnesota Medical Technologies | 2025-07-22 |
| RENEW INSERT (K122003) | Renew Medical, Inc. | 2012-10-26 |
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