K173223 - ologen Collagen Matrix (FDA 510(k) Clearance)

K173223 is an FDA 510(k) clearance for the ologen Collagen Matrix. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Aeon Astron Europe B.V. (Leiden, NL). The FDA issued a Cleared decision on March 2, 2018 after a review of 150 days - an extended review 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Aeon Astron Europe B.V. devices