K223310 - Antimicrobial Silicone PHMB Foam Wound Dressing (FDA 510(k) Clearance)

K223310 is an FDA 510(k) clearance for the Antimicrobial Silicone PHMB Foam Wound Dressing. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Advanced Medical Solutions Limited (Winsford, GB). The FDA issued a Cleared decision on April 5, 2023 after a review of 159 days - an extended review 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. Standard predicate reliance. 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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