K160872 - PolyPlex Wound Dressing (FDA 510(k) Clearance)

K160872 is an FDA 510(k) clearance for the PolyPlex Wound Dressing. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Global Health Solutions, LLC (Rome, US). The FDA issued a Cleared decision on November 23, 2016 after a review of 238 days - an extended review cycle.

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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