K113564 - EXSALT T7 WOUND DRESSING (FDA 510(k) Clearance)

K113564 is an FDA 510(k) clearance for the EXSALT T7 WOUND DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Exciton Technologies, Inc. (Edmonton, Alberta, CA). The FDA issued a Cleared decision on December 15, 2011 after a review of 13 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.