FDA 510(k) Application Details - K242473

Device Classification Name	More FDA Info for this Device
510(K) Number	K242473
Device Name	Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562)
Applicant	Coloplast Corp 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	PAH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/20/2024
Decision Date	10/18/2024
Decision	SESE - SUBST EQUIV
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