K171645 - CoMatryx Collagen Wound Dressing 1 gram pouch, CoMatryx Collagen Wound Dressing 1 gram vial, CoMatryx Collagen Wound Dressing 10 gram bottle (FDA 510(k) Clearance)

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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