Cleared Traditional

K120250 - FIBRILLAR COLLAGEN WOUND DRESSING

K120250 · Collafirm, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2013
Decision
450d
Days
-
Risk

K120250 is an FDA 510(k) clearance for the FIBRILLAR COLLAGEN WOUND DRESSING. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Collafirm, LLC (Monmouth Jct, US). The FDA issued a Cleared decision on April 21, 2013 after a review of 450 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

FDA 510(k) Submission Details - K120250

510(k) Number K120250 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2012
Decision Date April 21, 2013
Days to Decision 450 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
335d slower than avg
Panel avg: 115d · This submission: 450d
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 184
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K120250.
MARIGEN WOUND DRESSING
K132343 · Kerecis Limited · Oct 2013
COVAGEN
K123756 · Covalon Technologies, Ltd. · Aug 2013
PRIMATRIX DERMAL REPAIR SCAFFOLD
K131286 · Tei Biosciences, Inc. · Aug 2013
SENTREX BIOSPONGE MPD
K123961 · Bionova Medical, Inc. · Apr 2013
BRIDGE EXTRACELLULAR COLLEGEN MATRIX
K122502 · Harbor Medtech, Inc. · Feb 2013
COLLAGEN DENTAL WOUND DRESSINGS
K122115 · Collagen Matrix, Inc. · Nov 2012
K120250 · FIBRILLAR COLLAGEN WOUND DRESSING
Download PDF FDA Summary Collafirm, LLC