K171727 - Hydrocleanse Antimicrobial Skin and Wound Care Solution (FDA 510(k) Clearance)

K171727 is an FDA 510(k) clearance for the Hydrocleanse Antimicrobial Skin and Wound Care Solution. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Sonoma Pharmaceuticals (Petaluma, US). The FDA issued a Cleared decision on July 26, 2017 after a review of 44 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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