Cleared Traditional

K092096 - ENDOFORM DERMAL TEMPLATE

K092096 · Mesynthes, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2010
Decision
191d
Days
-
Risk

K092096 is an FDA 510(k) clearance for the ENDOFORM DERMAL TEMPLATE. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Mesynthes, Ltd. (North Attleboro, US). The FDA issued a Cleared decision on January 21, 2010 after a review of 191 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 Mesynthes, Ltd. devices

FDA 510(k) Submission Details - K092096

510(k) Number K092096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2009
Decision Date January 21, 2010
Days to Decision 191 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
76d slower than avg
Panel avg: 115d · This submission: 191d
Pathway characteristics
Predicate-based equivalence.

KGN Device Classification - Class 0,

Product Code KGN Wound Dressing With Animal-derived Material(s)
Device Class -

Regulatory Peers - KGN Wound Dressing With Animal-derived Material(s)

All 119
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K092096.
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PRIMATRIX DERMAL REPAIR SCAFFOLD
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