ACRYDERM ANTIMICROBIAL SILVER GEL WOUND DRESSING MODEL #B (K083103) - FDA 510(k) Clearance

K083103 is an FDA 510(k) clearance for the ACRYDERM ANTIMICROBIAL SILVER GEL WOUND DRESSING MODEL #B. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Acrymed, Inc. (Beaverton, US). The FDA issued a Cleared decision on February 26, 2009 after a review of 129 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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