Cleared Traditional

GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar

K173019 · Ethicon, Inc. · Gastroenterology & Urology

Jul 2018

Decision

281d

Days

Class 2

Risk

About This 510(k) Submission

K173019 is an FDA 510(k) clearance for the GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar, a Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence (Class II — Special Controls, product code PWJ), submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on July 6, 2018, 281 days after receiving the submission on September 28, 2017. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 884.4910.

Submission Details

510(k) Number	K173019 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 28, 2017
Decision Date	July 06, 2018
Days to Decision	281 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	PWJ — Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 884.4910
Definition	Used To Aid In Insertion, Placement, Fixation, Or Anchoring Of Surgical Mesh For Stress Urinary Incontinence