Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle)
FDA 510(k) clearance K243367 · decided 2025-07-22
Clearance details
- K-number
- K243367
- Device name
- Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle)
- Applicant
- Minnesota Medical Technologies
- Decision
- Substantially Equivalent
- Date received
- 2024-10-30
- Decision date
- 2025-07-22
- Days to decision
- 265 days
- Clearance type
- Traditional
- Product code
- PBP
- Device class
- 2
- Regulation number
- 876.5980
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Stewartville, MN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Minnesota Medical Technologies
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| RENEW INSERT (K122003) | Renew Medical, Inc. | 2012-10-26 |
Recalls involving this device
No recalls on record reference this clearance.