Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle)— 510(k) K243367

Name: FDA 510(k) clearance K243367
Creator: U.S. Food and Drug Administration
Published: 2025-07-22

Substantially Equivalent

Minnesota Medical Technologies

FDA 510(k) clearance K243367 for Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle), Substantially Equivalent on 2025-07-22. Applicant: Minnesota Medical Technologies. Device class: 2.

Clearance details

Applicant: Minnesota Medical Technologies
Product code: Code PBP
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 2024-10-30
Decision date: 2025-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stewartville, MN, US

Download summary PDF View on FDA.gov ↗

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