K190819 - Silicone PHMB Foam Wound Dressing (FDA 510(k) Clearance)

K190819 is an FDA 510(k) clearance for the Silicone PHMB Foam Wound Dressing. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Advanced Medical Solutions, Ltd. (Winsford, GB). The FDA issued a Cleared decision on July 25, 2019 after a review of 115 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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