K110458 - SILVER ANTIMICROBIAL WOUND GEL (FDA 510(k) Clearance)

K110458 is an FDA 510(k) clearance for the SILVER ANTIMICROBIAL WOUND GEL. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Advanced Medical Solutions Limited (Winsford Cheshire, GB). The FDA issued a Cleared decision on March 14, 2011 after a review of 25 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Advanced Medical Solutions Limited devices