Cleared Traditional

K123756 - COVAGEN

K123756 · Covalon Technologies, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2013
Decision
252d
Days
-
Risk

K123756 is an FDA 510(k) clearance for the COVAGEN. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Covalon Technologies, Ltd. (Mississauga, Ontario, CA). The FDA issued a Cleared decision on August 16, 2013 after a review of 252 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 Covalon Technologies, Ltd. devices

FDA 510(k) Submission Details - K123756

510(k) Number K123756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2012
Decision Date August 16, 2013
Days to Decision 252 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
137d slower than avg
Panel avg: 115d · This submission: 252d
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 179
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K123756.
MIROMATRIX WOUND MATRIX
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PRIMATRIX DERMAL REPAIR SCAFFOLD
K131286 · Tei Biosciences, Inc. · Aug 2013
FIBRILLAR COLLAGEN WOUND DRESSING
K120250 · Collafirm, LLC · Apr 2013
SENTREX BIOSPONGE MPD
K123961 · Bionova Medical, Inc. · Apr 2013