Cleared Traditional

K132343 - MARIGEN WOUND DRESSING

K132343 · Kerecis Limited · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Oct 2013
Decision
85d
Days
-
Risk

K132343 is an FDA 510(k) clearance for the MARIGEN WOUND DRESSING. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Kerecis Limited (Isafjordur, IS). The FDA issued a Cleared decision on October 23, 2013 after a review of 85 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Kerecis Limited devices

FDA 510(k) Submission Details - K132343

510(k) Number K132343 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2013
Decision Date October 23, 2013
Days to Decision 85 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
30d faster than avg
Panel avg: 115d · This submission: 85d
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 K132343.
BIO-CONNEKT WOUND MATRIX
K140456 · MLM Biologics, Inc. · Jul 2014
MIROMATRIX WOUND MATRIX
K140510 · Miromatrix Medical, Inc. · Jun 2014
COLLACARE DENTAL
K133290 · Innocoll Pharmaceuticals · May 2014
COVAGEN
K123756 · Covalon Technologies, Ltd. · Aug 2013
PRIMATRIX DERMAL REPAIR SCAFFOLD
K131286 · Tei Biosciences, Inc. · Aug 2013
FIBRILLAR COLLAGEN WOUND DRESSING
K120250 · Collafirm, LLC · Apr 2013