K243367 is an FDA 510(k) clearance for the Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle). This device is classified as a Rectal Insert (Class II - Special Controls, product code PBP).
Submitted by Minnesota Medical Technologies (Stewartville, US). The FDA issued a Cleared decision on July 22, 2025, 265 days after receiving the submission on October 30, 2024.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980. Acts As A Barrier To The Passage Of Fecal Matter Through The Rectum..
| 510(k) Number | K243367 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 30, 2024 |
| Decision Date | July 22, 2025 |
| Days to Decision | 265 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | PBP - Rectal Insert |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5980 |
| Definition | Acts As A Barrier To The Passage Of Fecal Matter Through The Rectum. |