510(k) K173019

GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar by ETHICON, Inc. — Product Code PWJ

K173019 is an FDA 510(k) premarket notification submitted by ETHICON, Inc. for the device "GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar". The FDA issued a decision of Substantially Equivalent on July 6, 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.