KerraContact Ag Perf Advanced Perforated Silver Wound Dressing (K182680) - FDA 510(k) Clearance

K182680 is an FDA 510(k) clearance for the KerraContact Ag Perf Advanced Perforated Silver Wound Dressing. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Exciton Technologies, Inc. (Edmonton, CA). The FDA issued a Cleared decision on December 6, 2018 after a review of 71 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 Exciton Technologies, Inc. devices