Cleared Traditional

K122502 - BRIDGE EXTRACELLULAR COLLEGEN MATRIX

K122502 · Harbor Medtech, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Feb 2013
Decision
194d
Days
-
Risk

K122502 is an FDA 510(k) clearance for the BRIDGE EXTRACELLULAR COLLEGEN MATRIX. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Harbor Medtech, Inc. (Irvine, US). The FDA issued a Cleared decision on February 26, 2013 after a review of 194 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 Harbor Medtech, Inc. devices

FDA 510(k) Submission Details - K122502

510(k) Number K122502 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2012
Decision Date February 26, 2013
Days to Decision 194 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
79d slower than avg
Panel avg: 115d · This submission: 194d
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 105
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K122502.
MicroMatrix
K153754 · Acell, Inc. · Mar 2016
Cytal Wound Matrix
K152721 · Acell, Inc. · Dec 2015
Dental Collagen Wound Dressing (Nova Tape and NovaPlug)
K142712 · Novabone Products, LLC · Jan 2015
COLLAGEN DENTAL WOUND DRESSINGS
K122115 · Collagen Matrix, Inc. · Nov 2012
INTEGRA WOUND MATRIX (THIN)
K113104 · Integra LifeSciences Corporation · Feb 2012
MATRISTEM WOUND MATRIX
K112409 · Acell, Inc. · Aug 2011