K100429 - URGOCELL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVER (FDA 510(k) Clearance)

K100429 is an FDA 510(k) clearance for the URGOCELL AG, ANTIMICROBIAL 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 June 11, 2010 after a review of 115 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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