Cleared Traditional

K100936 - GYNECARE TVT ABBREVO CONTINENCE SYSTEM

K100936 is the FDA 510(k) clearance for GYNECARE TVT ABBREVO CONTINENCE SYSTEM by Ethicon, Inc.. It is a Class 2 Gastroenterology & Urology device (product code OTN) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K100936 · Ethicon, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Jul 2010
Decision
87d
Days
Class 2
Risk

K100936 is an FDA 510(k) clearance for the GYNECARE TVT ABBREVO CONTINENCE SYSTEM. Classified as Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator (product code OTN), Class II - Special Controls.

Submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on July 1, 2010 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 878.3300 - the FDA gastroenterology and urology 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ethicon, Inc. devices

Submission Details

510(k) Number K100936 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2010
Decision Date July 01, 2010
Days to Decision 87 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 130d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
Definition Surgical Treatment Of Female Stress Urinary Incontinence Due To Intrinsic Sphincter Deficiency (isd) And/or Urethral Hypermobility
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

All 33
Devices cleared under the same product code (OTN) and FDA review panel - the closest regulatory comparables to K100936.
GYNECARE TVT EXACT CONTINENCE SYSTEM
K132054 · Ethicon, Inc. · Aug 2013
BLUE SUI SLING
K121754 · Boston Scientific Corp · Oct 2012
SUPRIS RETROPUBIC SLING SYSTEM
K111233 · Coloplast A/S · Jun 2011
ALIGN AND ALIGN TO URETHRAL SUPPORT SYSTEMS
K093747 · C.R. Bard, Inc. · May 2010
GYNECARE TVT EXACT CONTINENCE SYSTEM
K100485 · Ethicon, Inc. · Mar 2010
SPARC SYSTEM / MONARC, MONARC C, MONARC + SYSTEMS
K081613 · American Medical Systems, Inc. · Sep 2008