Cleared Traditional

K171645 - CoMatryx Collagen Wound Dressing 1 gram...

K171645 · Strukmyer Medical · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Jul 2017
Decision
50d
Days
-
Risk

K171645 is an FDA 510(k) clearance for the CoMatryx Collagen Wound Dressing 1 gram pouch, CoMatryx Collagen Wound Dressi.... Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Strukmyer Medical (Mesquite, US). The FDA issued a Cleared decision on July 25, 2017 after a review of 50 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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FDA 510(k) Submission Details - K171645

510(k) Number K171645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2017
Decision Date July 25, 2017
Days to Decision 50 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
65d faster than avg
Panel avg: 115d · This submission: 50d
Pathway characteristics
Predicate-based equivalence.

KGN Device Classification - Class 0,

Product Code KGN Wound Dressing With Animal-derived Material(s)
Device Class -

Regulatory Peers - KGN Wound Dressing With Animal-derived Material(s)

All 105
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K171645.
ologen Collagen Matrix
K173223 · Aeon Astron Europe B.V. · Mar 2018
Geistlich Wound Matrix
K171842 · Geistlich Pharma AG · Nov 2017
MicroMatrix
K172399 · Acell, Inc. · Oct 2017
Collagen Dental Wound Dressings
K152600 · Collagen Matrix, Inc. · Jun 2016
MicroMatrix
K153754 · Acell, Inc. · Mar 2016
Cytal Wound Matrix
K152721 · Acell, Inc. · Dec 2015