FDA 510(k) Applications for Medical Device Product Code "KGN"
(Dressing, Wound, Collagen)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K092926 | ACELL, INC | ACELL MATRISTEM WOUND SHEET | 10/28/2009 |
| K060888 | ACELL, INC | ACELL POWDER WOUND DRESSING | 06/23/2006 |
| K022854 | ACELL, INC | ACELL UBM HYDRATED WOUND DRESSING | 12/30/2002 |
| K021637 | ACELL, INC | ACELL UBM LYOPHILIZED WOUND DRESSING | 12/19/2002 |
| K152721 | ACELL, INC | Cytal Wound Matrix | 12/08/2015 |
| K112409 | ACELL, INC | MATRISTEM WOUND MATRIX | 08/29/2011 |
| K153754 | ACELL, INC | MicroMatrix | 03/14/2016 |
| K192725 | ACell, Inc. | Cytal Wound Matrix 3-Layer | 10/25/2019 |
| K180776 | ACell, Inc. | Cytal Wound Particulate | 05/11/2018 |
| K172399 | ACell, Inc. | MicroMatrix | 10/06/2017 |
| K230980 | ACell, Inc. | MicroMatrix« Flex | 09/22/2023 |
| K162348 | ACRO BIOMEDICAL CO., LTD | ABCcolla Collagen Matrix | 05/10/2017 |
| K000054 | ADRI | FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING WITH COLLAGEN | 03/13/2000 |
| K003134 | ADRI/TECHNAM | FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING | 12/22/2000 |
| K080868 | AEON ASTRON EUROPE B.V. | AONGEN COLLAGEN MATRIX | 05/14/2009 |
| K173223 | Aeon Astron Europe B.V. | ologen Collagen Matrix | 03/02/2018 |
| K081724 | APPLIED NUTRITIONALS | HYDROLYZED COLLAGEN WITH 10% CHONDROITIN SULFATE (PSGAG, POLYSULFATED GLYCOSAMINOGLYCAN) WOUND GEL | 10/30/2008 |
| K171231 | Aroa Biosurgery | Endoform Topical Matrix | 06/14/2017 |
| K200502 | Aroa Biosurgery Ltd. | Myriad Particles | 03/31/2021 |
| K200413 | Aroa Biosurgery Ltd. | Symphony | 07/29/2020 |
| K082869 | AUBREY, INC. | AWBAT-S, AWBAT-D, AWBAT-M | 02/06/2009 |
| K012990 | BIOCORE MEDICAL TECHNOLOGIES, INC. | COLLATEK POWDER | 10/24/2001 |
| K134037 | BIOTIME, INC. | PREMVIA | 08/07/2014 |
| K113866 | BRENNEN MEDICAL, LLC | PORCINE DERMAL XENOGRAFTS PORCINE DERMAL MATRIX | 03/23/2012 |
| K182010 | Cell Constructs I, LLC | ProgenaMatrix | 01/17/2019 |
| K120250 | COLLAFIRM LLC | FIBRILLAR COLLAGEN WOUND DRESSING | 04/21/2013 |
| K122115 | COLLAGEN MATRIX, INC. | COLLAGEN DENTAL WOUND DRESSINGS | 11/01/2012 |
| K152600 | COLLAGEN MATRIX, INC. | Collagen Dental Wound Dressings | 06/23/2016 |
| K030921 | COLLAGEN MATRIX, INC. | COLLAGEN TOPICAL WOUND DRESSING | 05/15/2003 |
| K040403 | COLLAGEN MATRIX, INC. | COLLAGEN WOUND DRESSING - ORAL | 05/10/2004 |
| K213341 | Collagen Matrix, Inc. | Fibrillar Collagen Wound Dressing | 05/31/2022 |
| K040211 | COLLAGEN MATRIX, INC. | MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING | 02/27/2004 |
| K040558 | COLLAGEN MATRIX, INC. | MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING | 03/17/2004 |
| K061474 | COLLAMATRIX CO., INC. | COLLAWOUND DRESSING | 07/05/2006 |
| K070269 | COLLAMATRIX CO., INC. | MODIFICATION TO COLLAWOUND DRESSING | 03/02/2007 |
| K984388 | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS | HA ABSORBENT WOUND DRESSING | 03/03/1999 |
| K990964 | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS | SIGNADRESS DUODERM DRESSING | 05/18/1999 |
| K152033 | Cook Biotech Incorporated | Cook ECM Powder | 08/19/2015 |
| K160136 | COOK BIOTECH INCORPORATED | Flowable Wound Matrix | 09/28/2016 |
| K061711 | COOK BIOTECH, INC. | OASIS WOUND MATRIX | 07/19/2006 |
| K973170 | COOK BIOTECH, INC. | SIS WOUND DRESSING | 04/30/1998 |
| K993948 | COOK BIOTECH, INC. | SIS WOUND DRESSING II | 01/06/2000 |
| K020732 | COOK BIOTECH, INC. | SS MATRIX | 05/30/2002 |
| K102946 | CORELEADER BIOTECH CO., LTD. | CORELEADER COLLA-PAD MODEL CS 03030 | 05/20/2011 |
| K123756 | COVALON TECHNOLOGIES LTD. | COVAGEN | 08/16/2013 |
| K050177 | COVALON TECHNOLOGIES, INC. | COLACTIVE COLLAGEN WOUND DRESSING | 04/27/2005 |
| K112580 | DALIM TISSEN CO., LTD. | COLLAGEN WOUND DRESSING | 06/01/2012 |
| K040314 | ENCOLL CORP. | HEALICOLL | 08/12/2004 |
| K192346 | Freudenberg Technology Innovation SE & Co. KG | scaffolene CL100 Bioresorbable Collagen Matrix | 02/28/2020 |
| K182838 | Geistlich Pharma AG | Geistlich Derma-Gide | 11/08/2018 |
| K171842 | Geistlich Pharma AG | Geistlich Wound Matrix | 11/03/2017 |
| K213607 | Geistlich Pharma AG | Geistlich Wound Matrix PLUS | 04/28/2022 |
| K191992 | Gunze Limited | PELNAC Bilayer Wound Matrix | 04/29/2020 |
| K213498 | Gunze Limited | PELNAC Meshed Bilayer Wound Matrix | 07/14/2022 |
| K213573 | Gunze Limited | PELNAC Wound Matrix | 02/09/2022 |
| K140367 | HARBOR MEDTECH, INC. | ARCHITECT PX EXTRACELLULAR COLLAGEN MATRIX | 09/12/2014 |
| K122502 | HARBOR MEDTECH, INC. | BRIDGE EXTRACELLULAR COLLEGEN MATRIX | 02/26/2013 |
| K091338 | HARTMANN-CONCO INC. | COLLASORB COLLAGEN WOUND DRESSING | 08/26/2009 |
| K213598 | Huizhou Foryou Medical Devices CO., Ltd. | LUOFUCON Collagen Wound Dressing | 09/20/2022 |
| K213092 | Human Biosciences, Inc. | Cellusheet, Cellufil | 12/15/2021 |
| K122325 | HUMAN BIOSCIENCES, INC. | SKINTEMP II | 10/26/2012 |
| K133290 | INNOCOLL PHARMACEUTICALS | COLLACARE DENTAL | 05/01/2014 |
| K092805 | INNOCOLL PHARMACEUTICALS | COLLAGEN SPONGE | 02/16/2010 |
| K061746 | INNOCOLL PHARMACEUTICALS | COLLAGUARD, MODEL FCIA,FCIB,FCIC,AND FCID | 10/02/2006 |
| K100574 | INNOCOLL PHARMACEUTICALS | COLLEXA | 10/28/2010 |
| K081782 | INNOCOLL PHARMACEUTICALS | COLLIEVA | 09/30/2008 |
| K120339 | INNOCOLL PHARMACEUTICALS | PROCOLL | 06/21/2012 |
| K110388 | INNOCOLL PHARMACEUTICALS LTD | COLLACARE DENTAL | 08/09/2011 |
| K103648 | INNOCOLL PHARMACEUTICALS LTD | COLLAGEN POWDER | 09/14/2011 |
| K022127 | INTEGRA LIFESCIENCES CORP. | AVAGEN WOUND DRESSING | 09/10/2002 |
| K021792 | INTEGRA LIFESCIENCES CORP. | BILAYER MATRIX WOUND DRESSING | 08/14/2002 |
| K072113 | INTEGRA LIFESCIENCES CORP. | INTEGRA FLOWABLE WOUND MATRIX, MODEL FWD301 | 10/10/2007 |
| K081635 | INTEGRA LIFESCIENCES CORP. | INTEGRA MESHED BILAYER WOUND MATRIX | 12/04/2008 |
| K210128 | Integra LifeSciences Corporation | INTEGRA Wound Matrix (Macro-Channels) | 10/08/2021 |
| K113104 | INTEGRA LIFESCIENCES CORPORATION | INTEGRA WOUND MATRIX (THIN) | 02/09/2012 |
| K982597 | JOHNSON & JOHNSON MEDICAL, INC. | FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATE | 08/20/1998 |
| K970266 | KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH | KENDALL HYDROPHILIC POWDER WOUND DRESSING | 04/23/1997 |
| K112888 | KENSEY NASH CORPORATION | MESO WOUND MATRIX | 02/10/2012 |
| K141738 | KENSEY NASH CORPORATION DBA DSM BIOMEDICAL | MEDEOR MATRIX WOUND DRESSING | 02/17/2015 |
| K192386 | KeraNetics | KeraStat Cream | 07/16/2020 |
| K162759 | KeraNetics, LLC. | KeraStat(R) Gel | 06/02/2017 |
| K213231 | Kerecis Limited | Kerecis Silicone | 06/29/2022 |
| K132343 | KERECIS LIMITED | MARIGEN WOUND DRESSING | 10/23/2013 |
| K190528 | Kerecis Limited | MariGen Wound Extra | 07/10/2019 |
| K082103 | LIFECELL CORP. | LTM WOUND DRESSING | 10/08/2008 |
| K100927 | MAXIGEN BIOTECH, INC. | SURGIAID | 02/02/2011 |
| K060456 | MEDLINE INDUSTRIES, INC. | MEDLINE COLLAGEN WOUND DRESSING | 06/19/2006 |
| K201577 | MedSkin Solutions Dr. Suwelack AG | MatriDerm | 01/07/2021 |
| K000487 | MEDTRADE PRODUCTS LTD. | MEDTRADE PRODUCTS ALGINATE ISLAND | 04/18/2000 |
| K101546 | MESYNTHES LTD | ENDOFORM DENTAL TEMPLATE | 06/23/2010 |
| K092096 | MESYNTHES LTD | ENDOFORM DERMAL TEMPLATE | 01/21/2010 |
| K140510 | MIROMATRIX MEDICAL INC. | MIROMATRIX WOUND MATRIX | 06/19/2014 |
| K143426 | MIROMATRIX MEDICAL INC. | Wound Matrix TF | 01/27/2015 |
| K140456 | MLM BIOLOGICS, INC. | BIO-CONNEKT WOUND MATRIX | 07/22/2014 |
| K210024 | NeXtGen Biologics, Inc. | NeoMatriX Wound Matrix | 10/07/2021 |
| K181330 | NeXtGen Biologics, Inc. | NeoMatriX Wound Matrix | 10/11/2018 |
| K142712 | NovaBone Products, LLC | Dental Collagen Wound Dressing (Nova Tape and NovaPlug) | 01/08/2015 |
| K220498 | Novabone Products, LLC | NovoGen Wound Matrix | 06/09/2023 |
| K002443 | OASIS RESEARCH, LLC. | COLLAGEN WOUND DRESSING | 10/18/2000 |
| K212579 | Organogenesis Inc. | FortiShield (Biosynthetic Wound Matrix) | 05/02/2023 |
| K220317 | Organogenesis Inc. | PuraPly Micronized Wound Matrix (PuraPly MZ) | 07/01/2022 |
| K011026 | ORGANOGENESIS, INC. | FORTADERM WOUND DRESSING | 06/13/2001 |
| K061494 | PEGASUS BIOLOGICS, INC. | DERMADAPT WOUND DRESSING | 09/21/2006 |
| K071425 | PEGASUS BIOLOGICS, INC. | UNITE BIOMATRIX | 06/20/2007 |
| K223257 | Reprise Biomedical | Miro3D Wound Matrix | 11/21/2022 |
| K221520 | Reprise Biomedical, Inc. | Miro3D Wound Matrix | 08/18/2022 |
| K090812 | SEWON CELLONTECH CO., LTD. | THERAFORM STANDARD/SHEET | 07/30/2009 |
| K030774 | SOUTHWEST TECHNOLOGIES, INC. | STIMULEN COLLAGEN | 08/09/2004 |
| K172593 | StemSys | XCelliStem Wound Powder | 03/16/2018 |
| K171645 | Strukmyer Medical | CoMatryx Collagen Wound Dressing 1 gram pouch, CoMatryx Collagen Wound Dressing 1 gram vial, CoMatryx Collagen Wound Dressing 10 gram bottle | 07/25/2017 |
| K112399 | SYNOVIS ORTHOPEDIC & WOUNDCARE | UNITE BIOMATRIX | 09/07/2011 |
| K023778 | TEI BIOSCIENCES INC. | DRESSSKIN | 09/29/2003 |
| K061407 | TEI BIOSCIENCES INC. | PRIMATRIX DERMAL REPAIR SCAFFOLD | 06/29/2006 |
| K083440 | TEI BIOSCIENCES INC. | PRIMATRIX DERMAL REPAIR SCAFFOLD | 12/12/2008 |
| K131286 | TEI BIOSCIENCES INC. | PRIMATRIX DERMAL REPAIR SCAFFOLD | 08/05/2013 |
| K153690 | TEI BioSciences Inc. | PriMatrix Dermal Repair Scaffold | 02/22/2016 |
| K955506 | THE HYMED GROUP CORP. | HYCURE | 01/17/1996 |
| K994339 | THE HYMED GROUP CORP. | HYCURE ORAL / HYCURE ORAL SMART GEL | 03/22/2000 |
| K110318 | TISSUE REPAIR COMPANY | EXCELLAGEN | 10/03/2011 |
| K213716 | Triad Life Sciences, Inc. | InnovaBurn | 09/29/2022 |
| K193552 | Triad Life Sciences, Inc. | InnovaMatrix | 10/21/2020 |
| K210580 | Triad Life Sciences, Inc. | InnovaMatrix FS | 04/21/2021 |
| K211902 | Triad Life Sciences, Inc. | InnovaMatrix PD | 09/28/2022 |
| K140820 | VISCUS BIOLOGICS LLC | XENOMEM WOUND MATRIX | 06/26/2015 |
| K090954 | WRIGHT MEDICAL TECHNOLOGY, INC. | ATLAS WOUND MATRIX | 07/30/2009 |
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