Cleared Traditional

GORE-TEX(TM) DUAL MESH (K926565) - FDA 510(k) Clearance

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

K926565 · W.L. Gore & Associates, Inc. · General & Plastic Surgery device
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Sep 1993
Decision
252d
Days
Class 2
Risk

K926565 is an FDA 510(k) clearance for the GORE-TEX(TM) DUAL MESH. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by W.L. Gore & Associates, Inc. (Flagstaff, US). The FDA issued a Cleared decision on September 9, 1993 after a review of 252 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3300 - 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 W.L. Gore & Associates, Inc. devices

Submission Details

510(k) Number K926565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 1992
Decision Date September 09, 1993
Days to Decision 252 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
137d slower than avg
Panel avg: 115d · This submission: 252d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FTL Mesh, Surgical, Polymeric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
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.

Regulatory Peers - FTL Mesh, Surgical, Polymeric

All 106
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K926565.
SURGICAL FABRICS
K963226 · Boston Scientific Corp · Nov 1996
PROLENE POLYPROPYLENE MESH NONABSORBABLE SYNTHETIC SURGICAL MESH
K962530 · Ethicon, Inc. · Aug 1996
GIANTURCO-HELFRICH HERNIS MESH
K931936 · Cook, Inc. · Jan 1994
AUTO SUTURE SURGICAL MESH DEPLOYER
K925148 · United States Surgical, A Division of Tyco Healthc · Feb 1993
BARD MARLEX MESH DART
K922916 · C.R. Bard, Inc. · Aug 1992
COATED SURGIPRO(TM) POLYPROPYLENE SURGICAL MESH
K915526 · United States Surgical, A Division of Tyco Healthc · May 1992