Cleared Traditional

GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide

K173162 · Ethicon, Inc. · Gastroenterology & Urology

Jun 2018

Decision

272d

Days

Class 2

Risk

About This 510(k) Submission

K173162 is an FDA 510(k) clearance for the GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, 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 June 28, 2018, 272 days after receiving the submission on September 29, 2017. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 884.4910.

Submission Details

510(k) Number	K173162 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 29, 2017
Decision Date	June 28, 2018
Days to Decision	272 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