K243367
- 510(k) number
- K243367
- Device name
- Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle)
- Applicant
- Minnesota Medical Technologies MN · US
- Product code
- PBP — Rectal Insert
- Decision date
- 2025-07-22
- Date received
- 2024-10-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K243367.pdf
Official FDA record: K243367
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.