About This 510(k) Submission
K201686 is an FDA 510(k) clearance for the 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, a Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator (Class II — Special Controls, product code OTN), submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on September 17, 2020, 87 days after receiving the submission on June 22, 2020. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 878.3300.