Product code PBP— Gastroenterology, Urology
Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle)
- Classification name
- Rectal Insert
- Device class
- Class 2
- Regulation
- 21 CFR 876.5980
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 2
- First cleared
- Most recent
FDA classification definition
“Acts as a barrier to the passage of fecal matter through the rectum.”
Market context for product code PBP
FDA has cleared devices under product code PBP between 2012 and 2025, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2025
- 2012
Top applicants under product code PBP
Recent clearances under product code PBP
Data sourced from openFDA. This site is unofficial and independent of the FDA.