Cleared Traditional

K946106 - GORE-TEX DUALMESH PLUS BIOMATERIAL

K946106 is the FDA 510(k) clearance for GORE-TEX DUALMESH PLUS BIOMATERIAL 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 131-day FDA review.

K946106 · W.L. Gore & Associates, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Apr 1995
Decision
131d
Days
Class 2
Risk

K946106 is an FDA 510(k) clearance for the GORE-TEX DUALMESH PLUS BIOMATERIAL. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by W.L. Gore & Associates, Inc. (Elkton, US). The FDA issued a Cleared decision on April 24, 1995 after a review of 131 days - within the typical 510(k) review window.

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 K946106 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1994
Decision Date April 24, 1995
Days to Decision 131 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
16d slower than avg
Panel avg: 115d · This submission: 131d
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 K946106.
GORE-TEX MYCROMESH BIOMATERIAL
K951675 · W.L. Gore & Associates, Inc. · Oct 1995
GORE-TEX DUALMESH BIOMATERIAL
K951676 · W.L. Gore & Associates, Inc. · Oct 1995
GORE-TEX SOFT TISSUE PATCH
K951700 · W.L. Gore & Associates, Inc. · Oct 1995
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