K172622 - Microcyn Antimicrobial Skin and Wound Cleanser (FDA 510(k) Clearance)

K172622 is an FDA 510(k) clearance for the Microcyn Antimicrobial Skin and Wound Cleanser. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Sonoma Pharmaceuticals (Petaluma, US). The FDA issued a Cleared decision on November 21, 2017 after a review of 81 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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