Cleared Traditional

K955494 - GORE-TEX DUALMESH BIOMATERIAL WITH HOLES

K955494 is an FDA 510(k) clearance for GORE-TEX DUALMESH BIOMATERIAL WITH HOLES, manufactured by W.L. Gore & Associates, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTL cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K955494 · W.L. Gore & Associates, Inc. · General & Plastic Surgery device
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Jan 1996
Decision
54d
Days
Class 2
Risk

K955494 is an FDA 510(k) clearance for the GORE-TEX DUALMESH BIOMATERIAL WITH HOLES. 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 January 24, 1996 after a review of 54 days - a notably fast clearance 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: 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 W.L. Gore & Associates, Inc. devices

FDA 510(k) Submission Details - K955494

510(k) Number K955494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1995
Decision Date January 24, 1996
Days to Decision 54 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
61d faster than avg
Panel avg: 115d · This submission: 54d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FTL Device Classification - Class 2, Special Controls

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 300
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K955494.
SOFT TISSUE AUGMENTATION TUBE
K960481 · Tissue Technologies, Inc. · Apr 1996
PROLEX MESH
K960219 · Advanced Surgical Innovations, Inc. · Mar 1996
GLYCAR STAPLE STRIPS
K954665 · Glycar, Inc. · Feb 1996
GORE-TEX SAM FACIAL IMPLANT WITH INTRODUCER
K952898 · W.L. Gore & Associates, Inc. · Nov 1995
GORE-TEX MYCROMESH BIOMATERIAL
K951675 · W.L. Gore & Associates, Inc. · Oct 1995
GORE-TEX DUALMESH BIOMATERIAL
K951676 · W.L. Gore & Associates, Inc. · Oct 1995