K210974 - High Performance Antimicrobial Gelling Fiber with Silver (FDA 510(k) Clearance)

K210974 is an FDA 510(k) clearance for the High Performance Antimicrobial Gelling Fiber with Silver. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Advanced Medical Solutions, Ltd. (Winsford, GB). The FDA issued a Cleared decision on May 12, 2021 after a review of 41 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.

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