Cleared Traditional

K122115 - COLLAGEN DENTAL WOUND DRESSINGS

K122115 · Collagen Matrix, Inc. · General & Plastic Surgery device
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Nov 2012
Decision
107d
Days
-
Risk

K122115 is an FDA 510(k) clearance for the COLLAGEN DENTAL WOUND DRESSINGS. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Collagen Matrix, Inc. (Oakland, US). The FDA issued a Cleared decision on November 1, 2012 after a review of 107 days - within the typical 510(k) review window.

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 Collagen Matrix, Inc. devices

FDA 510(k) Submission Details - K122115

510(k) Number K122115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2012
Decision Date November 01, 2012
Days to Decision 107 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 115d · This submission: 107d
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 151
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K122115.
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SKINTEMP II
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PROCOLL
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HEALEX BIOSPONGE WOUND DRESSING
K112191 · Bionova Medical, Inc. · Jun 2012