510(k) K173162

GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide by ETHICON, Inc. — Product Code PWJ

K173162 is an FDA 510(k) premarket notification submitted by ETHICON, Inc. for the device "GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide". The FDA issued a decision of Substantially Equivalent on June 28, 2018. The device falls under product code PWJ (Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence), a Class II device regulated under 21 CFR 884.4910. ETHICON, Inc. has at least 10 other 510(k) clearances on record.