Cleared Traditional

K922452 - GORE-TEX SOFT TISSUE PATCH PLUS

K922452 is the FDA 510(k) clearance for GORE-TEX SOFT TISSUE PATCH PLUS by W.L. Gore & Associates, Inc.. It is a Class 2 General & Plastic Surgery device (product code FTL) cleared through the Traditional 510(k) pathway after a 856-day FDA review.

K922452 · W.L. Gore & Associates, Inc. · General & Plastic Surgery device
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Sep 1994
Decision
856d
Days
Class 2
Risk

K922452 is an FDA 510(k) clearance for the GORE-TEX SOFT TISSUE PATCH PLUS. 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 29, 1994 after a review of 856 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all W.L. Gore & Associates, Inc. devices

Submission Details

510(k) Number K922452 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 1992
Decision Date September 29, 1994
Days to Decision 856 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
741d slower than avg
Panel avg: 115d · This submission: 856d
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 187
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K922452.
GORE-TEX MYCROMESH PLUS BIOMATERIAL
K946107 · W.L. Gore & Associates, Inc. · Apr 1995
GORE-TEX(R) CURVED SURGICALMEMBRANE
K945899 · W.L. Gore & Associates, Inc. · Feb 1995
TRELEX NATURAL(R) MESH
K945377 · Meadox Medicals, Div. Boston Scientific Corp. · Dec 1994
GORE-TEX SOFT TISSUE PATCH,SURGICAL MEMBRANE,MESH
K930822 · W.L. Gore & Associates, Inc. · Jan 1994
GIANTURCO-HELFRICH HERNIS MESH
K931936 · Cook, Inc. · Jan 1994
ATRIUM POLYPROPYLENE MESH
K930669 · Atrium Medical Corp. · Dec 1993