K133542 - PURACYN PLUS SKIN AND WOUND (FDA 510(k) Clearance)

K133542 is an FDA 510(k) clearance for the PURACYN PLUS SKIN AND WOUND. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Innovacyn, Inc. (Rialto, US). The FDA issued a Cleared decision on April 28, 2014 after a review of 161 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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