FDA 510(k) Application Details - K243367

Device Classification Name	More FDA Info for this Device
510(K) Number	K243367
Device Name	Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle)
Applicant	Minnesota Medical Technologies 2446 Henry Road NW Stewartville, MN 55976 US Other 510(k) Applications for this Company
Contact	Robert Anglin Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PBP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/30/2024
Decision Date	07/22/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review