K143017 - Urgoclean Ag, Antibacterial Absorbent Wound Dressing with Silver (FDA 510(k) Clearance)

K143017 is an FDA 510(k) clearance for the Urgoclean Ag, Antibacterial Absorbent Wound Dressing with Silver. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Laboratoires Urgo (21300 Chenove, FR). The FDA issued a Cleared decision on August 7, 2015 after a review of 291 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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