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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
510(k) Number K201686
Device Name GYNECARE TVT™ System, GYNECARE TVT™ with Abdominal Guides System, GYNECARE TVT™ Introducer and Catheter Guide, GYNECARE TVT EXACT™ Continence System and Trocar, GYNECARE TVT™ Obturator System and Passers and Winged Guide, GYNECARE TVT ABBREVO™ Continence System and Passers and Winged Guide
Applicant
ETHICON, Inc.
Rte. 22 W.
Somerville,  NJ  08876
Applicant Contact Ariell Joiner
Correspondent
ETHICON, Inc.
Rte. 22 W.
Somerville,  NJ  08876
Correspondent Contact Ariell Joiner
Regulation Number878.3300
Classification Product Code
OTN  
Subsequent Product Code
PWJ  
Date Received06/22/2020
Decision Date 09/17/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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