FDA Product Code
FDA Product Code PBP — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5980
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K243367 | Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle) | Minnesota Medical Technologies | 2025-07-22 | Traditional | PDF ↗ |
| K122003 | RENEW INSERT | Renew Medical, Inc. | 2012-10-26 | Traditional | PDF ↗ |
Product code PBP · Class II · Gastroenterology, Urology. Data: openFDA.