MENDASIL TWG GEL ANTIMICROBIAL SKIN AND WOUND GEL (K090345) - FDA 510(k) Clearance

K090345 is an FDA 510(k) clearance for the MENDASIL TWG GEL ANTIMICROBIAL SKIN AND WOUND GEL. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Conseal International, Inc. (Norwood, US). The FDA issued a Cleared decision on January 7, 2010 after a review of 331 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Conseal International, Inc. devices