K213092 - Cellusheet, Cellufil (FDA 510(k) Clearance)

K213092 is an FDA 510(k) clearance for the Cellusheet, Cellufil. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Human Biosciences, Inc. (Gaithersburg, US). The FDA issued a Cleared decision on December 15, 2021 after a review of 82 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 Human Biosciences, Inc. devices