Cleared Traditional

GORE-TEX TISSUE REINFORCEMENT PATCH (K820193) - FDA 510(k) Clearance

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

K820193 · W.L. Gore & Associates, Inc. · General & Plastic Surgery device
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Mar 1982
Decision
60d
Days
Class 2
Risk

K820193 is an FDA 510(k) clearance for the GORE-TEX TISSUE REINFORCEMENT PATCH. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by W.L. Gore & Associates, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 26, 1982 after a review of 60 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

Submission Details

510(k) Number K820193 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1982
Decision Date March 26, 1982
Days to Decision 60 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 115d · This submission: 60d
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 K820193.
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
NONABSORBABLE POLYPROPYLENE SURGICAL MESH
K905655 · United States Surgical, A Division of Tyco Healthc · Dec 1990
VICRYL
K810428 · Ethicon, Inc. · Mar 1981