Cleared Traditional

GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System

K181151 · Ethicon, Inc. · General & Plastic Surgery
Aug 2018
Decision
101d
Days
Class 2
Risk

About This 510(k) Submission

K181151 is an FDA 510(k) clearance for the GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System, 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 August 10, 2018, 101 days after receiving the submission on May 1, 2018. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 884.4910.

Submission Details

510(k) Number K181151 FDA.gov
FDA Decision Cleared SESE
Date Received May 01, 2018
Decision Date August 10, 2018
Days to Decision 101 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
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

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