Cleared Traditional

K952898 - GORE-TEX SAM FACIAL IMPLANT WITH INTROD...

K952898 is the FDA 510(k) clearance for GORE-TEX SAM FACIAL IMPLANT WITH INTROD... 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 144-day FDA review.

K952898 · W.L. Gore & Associates, Inc. · General & Plastic Surgery device
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Nov 1995
Decision
144d
Days
Class 2
Risk

K952898 is an FDA 510(k) clearance for the GORE-TEX SAM FACIAL IMPLANT WITH INTRODUCER. 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 November 14, 1995 after a review of 144 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 K952898 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1995
Decision Date November 14, 1995
Days to Decision 144 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
29d slower than avg
Panel avg: 115d · This submission: 144d
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 K952898.
GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES
K962401 · W.L. Gore & Associates, Inc. · Sep 1996
PROLENE POLYPROPYLENE MESH NONABSORBABLE SYNTHETIC SURGICAL MESH
K962530 · Ethicon, Inc. · Aug 1996
GORE-TEX DUALMESH BIOMATERIAL WITH HOLES
K955494 · W.L. Gore & Associates, Inc. · Jan 1996
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