K123219 - URGOCLEAN ABSORBENT WOUND DRESSING (FDA 510(k) Clearance)

K123219 is an FDA 510(k) clearance for the URGOCLEAN ABSORBENT WOUND DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Laboratoires Urgo (Chevigny Saint Sauveur, FR). The FDA issued a Cleared decision on March 18, 2013 after a review of 154 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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