K101793 - MEDIHONEY GEL DRESSING WITH ACTIVE MANUKA HONEY (FDA 510(k) Clearance)

K101793 is an FDA 510(k) clearance for the MEDIHONEY GEL DRESSING WITH ACTIVE MANUKA HONEY. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Derma Sciences, Inc. (North Attleboro, US). The FDA issued a Cleared decision on February 22, 2011 after a review of 239 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.

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