FDA 510(k) Application Details - K173019

Device Classification Name	More FDA Info for this Device
510(K) Number	K173019
Device Name	GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar
Applicant	Ethicon Inc. Route 22 West Somerville, NJ 08876-0151 US Other 510(k) Applications for this Company
Contact	Melina Escobar Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PWJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/28/2017
Decision Date	07/06/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review