Cleared Traditional

K132397 - GORE BIO-A WOUND MATRIX

K132397 · W.L. Gore & Associates, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2014
Decision
279d
Days
-
Risk

K132397 is an FDA 510(k) clearance for the GORE BIO-A WOUND MATRIX. Classified as Absorbable Synthetic Wound Dressing (product code QSZ).

Submitted by W.L. Gore & Associates, Inc. (Elkton, US). The FDA issued a Cleared decision on May 7, 2014 after a review of 279 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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

FDA 510(k) Submission Details - K132397

510(k) Number K132397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2013
Decision Date May 07, 2014
Days to Decision 279 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
164d slower than avg
Panel avg: 115d · This submission: 279d
Pathway characteristics
Predicate-based equivalence.

QSZ Device Classification - Class 0,

Product Code QSZ Absorbable Synthetic Wound Dressing
Device Class -
Definition Intended As A Physical Barrier To Cover The Wound And Provide A Moist Wound Environment. Intended To Be Left On Wounds After Topical Application.

Regulatory Peers - QSZ Absorbable Synthetic Wound Dressing

All 17
Devices cleared under the same product code (QSZ) and FDA review panel - the closest regulatory comparables to K132397.
Restrata Wound Matrix
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Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen Advanced Wound Matrix, 1x6”
K161067 · Engineered Tissue Solutions, LLC · Sep 2016
BTM Wound Dressing
K142879 · Polynovo Biomaterials Pty, Ltd. · Dec 2015
HYALOMATRIX PA
K073251 · Fidia Advanced Biopolymers Srl · Dec 2007