Fish-Skin Tissue Regeneration Technology to Heal Human Wounds

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Fish-Skin Tissue Regeneration Technology to Heal Human Wounds

Drugs | Global | Regulatory Doctor

FDA 510(k)s | KGN

On October 23, 2013, the US FDA cleared a 510(k) [K132343] to market a proprietary fish-skin technology, marketed as MariGen Omega3, for the treatment of chronic wounds in the US.  The MariGen Omega3 is manufactured by Kerecis in Iceland from fish locally harvested in the North Atlantic waters.

[quote]Kerecis states “MariGen Omega3 products are intact, decellularized fish skin sheets, which have had all cells and antigenic materials removed. Fish skin is largely made from the same material as human skin, with the addition of Omega3 polyunsaturated fatty acids. When the product is inserted into or onto damaged human tissue, protease activity is modulated, the fish skin is vascularized and populated by the patient’s own cells, and ultimately converted into living tissue.”[/quote]

Device Classification Name: Dressing, Wound, Collagen

  • 510(K) Number K132343
  • Proprietary Name:  MariGen Omega3
  • Manufacturer: Kerecis
  • Classification Product Code:  KGN
  • TPLC Report TPLC-KGN
  • Date Received 08/07/2013
  • Decision Date 10/23/2013
  • Decision Substantially Equivalent (SE)
  • Classification Advisory Committee: General & Plastic Surgery
  • Review Advisory Committee: General & Plastic Surgery
  • 510(k) Type: Traditional

Read the firm’s announcement here.

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Recent 510(k)s Cleared under Product Code “KGN”

Device Name Applicant Name 510(k) Number Decision Date
Collagen Wound Dressing Kerecis Limited K132343 10/23/2013
Covagen Covalon Technologies Ltd. K123756 08/16/2013
Primatrix Dermal Repair Scaffold Tei Biosciences Inc. K131286 08/05/2013
Fibrillar Collagen Wound Dressing Collafirm Llc K120250 04/21/2013
Bridge Extracellular Collegen Matrix Harbor Medtech, Inc. K122502 02/26/2013
Collagen Dental Wound Dressings Collagen Matrix, Inc. K122115 11/01/2012
Skintemp Ii Human Biosciences, Inc. K122325 10/26/2012
Procoll Innonoll Pharmaceuticals Ltd. K120339 06/21/2012
Collagen Wound Dressing Dalim Tissen Co., Ltd. K112580 06/01/2012
Porcine Dermal Xenografts Porcine Dermal Brennen Medical, Llc K113866 03/23/2012

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