K113693 - NIXALL TM WOUND AND SKIN CARE (FDA 510(k) Clearance)

K113693 is an FDA 510(k) clearance for the NIXALL TM WOUND AND SKIN CARE. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Seriously Clean, Ltd. (Nixa, US). The FDA issued a Cleared decision on December 11, 2012 after a review of 361 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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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