Cleared Traditional

K120250 - FIBRILLAR COLLAGEN WOUND DRESSING

K120250 · Collafirm, LLC · General & Plastic Surgery device
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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.

View all Collafirm, LLC devices

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
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 105
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K120250.
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K112409 · Acell, Inc. · Aug 2011