ACRYDERM SILVER ANTIMICROBIAL PERFORATED WOUND DRESSING (K012116) - FDA 510(k) Clearance

K012116 is an FDA 510(k) clearance for the ACRYDERM SILVER ANTIMICROBIAL PERFORATED WOUND DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Acrymed, Inc. (Portland, US). The FDA issued a Cleared decision on September 12, 2001 after a review of 68 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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