K173896 - Microcyn Antimicrobial Hydrogel (FDA 510(k) Clearance)

K173896 is an FDA 510(k) clearance for the Microcyn Antimicrobial Hydrogel. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Sonoma Pharmaceuticals, Inc. (Petaluma, US). The FDA issued a Cleared decision on April 2, 2018 after a review of 101 days - within the typical 510(k) review window.

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.

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