Cleared Traditional

K090345 - MENDASIL TWG GEL ANTIMICROBIAL SKIN AND...

K090345 · Conseal International, Inc. · General & Plastic Surgery device
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Jan 2010
Decision
331d
Days
-
Risk

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

FDA 510(k) Submission Details - K090345

510(k) Number K090345 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2009
Decision Date January 07, 2010
Days to Decision 331 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
216d slower than avg
Panel avg: 115d · This submission: 331d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

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