K233399 - Microdacyn Wound Care Solution (FDA 510(k) Clearance)

K233399 is an FDA 510(k) clearance for the Microdacyn Wound Care Solution. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Sonoma Pharmaceuticals, Inc. (Petaluma, US). The FDA issued a Cleared decision on September 13, 2024 after a review of 345 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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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