UNITE BIOMATRIX (K071425) - FDA 510(k) Clearance

K071425 is an FDA 510(k) clearance for the UNITE BIOMATRIX. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Pegasus Biologics, Inc. (Irvine, US). The FDA issued a Cleared decision on June 20, 2007 after a review of 28 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 Pegasus Biologics, Inc. devices