Cleared Traditional

K181151 - GYNECARE TVT Abbrevo Continence System (FDA 510(k) Clearance)

Also includes:
GYNECARE TVT Obturator Continence System

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K181151 is an FDA 510(k) clearance for the GYNECARE TVT Abbrevo Continence System. Classified as Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence (product code PWJ), Class II - Special Controls.

Submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on August 10, 2018 after a review of 101 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 884.4910 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Ethicon, Inc. devices

Submission Details

510(k) Number K181151 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 114d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PWJ Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence
Device Class Class 2 - 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
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.