K150985 - Medihoney Wound Gel (FDA 510(k) Clearance)

K150985 is an FDA 510(k) clearance for the Medihoney Wound Gel. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Derma Sciences, Inc. (Toronto, Orntario, CA). The FDA issued a Cleared decision on November 19, 2015 after a review of 219 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Derma Sciences, Inc. devices