FDA 510(k) Application Details - K231891

Device Classification Name	More FDA Info for this Device
510(K) Number	K231891
Device Name	Virtue Male Sling System with Alexis Wound Retractor Convenience Kit
Applicant	Coloplast 1601 West River Road North Minneapolis, MN 55411 US Other 510(k) Applications for this Company
Contact	Jennifer Mrkvicka Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OTM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/27/2023
Decision Date	09/25/2023
Decision	SESK - SUBST EQUIV - KIT
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review