FDA 510(k) Application Details - K201686

Device Classification Name	More FDA Info for this Device
510(K) Number	K201686
Device Name	GYNECARE TVTÖ System, GYNECARE TVTÖ with Abdominal Guides System, GYNECARE TVTÖ Introducer and Catheter Guide, GYNECARE TVT EXACTÖ Continence System and Trocar, GYNECARE TVTÖ Obturator System and Passers and Winged Guide, GYNECARE TVT ABBREVOÖ Continence
Applicant	Ethicon Inc. Route 22 West Somerville, NJ 08876-0151 US Other 510(k) Applications for this Company
Contact	Ariell Joiner Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OTN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/22/2020
Decision Date	09/17/2020
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