K140483 - ASAP OTC WOUND DRESSING GEL (FDA 510(k) Clearance)

K140483 is an FDA 510(k) clearance for the ASAP OTC WOUND DRESSING GEL. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Abl Medical, LLC (Alexandria, US). The FDA issued a Cleared decision on May 20, 2014 after a review of 83 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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