Cleared Traditional

K171645 - CoMatryx Collagen Wound Dressing 1 gram pouch, CoMatryx Collagen Wound Dressing 1 gram vial, CoMatryx Collagen Wound Dressing 10 gram bottle

K171645 · Strukmyer Medical · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
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.

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
Combination Product No
PCCP Authorized No
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 182
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K171645.
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K162348 · Acro Biomedical Co., Ltd. · May 2017