Product Code: KGN
FDA unclassified
Wound Dressing With Animal-Derived Material(S)
Unknown
Wound Dressing with Animal-Derived Material(s) is a dressing incorporating biological components sourced from animals, such as collagen or other extracellular matrix materials, used to cover wounds and support healing through biologically active mechanisms. This device is currently unclassified by the FDA, meaning it has not yet been placed into Class 1, 2, or 3 through the classification process, and a 510(k) submission has been required pending classification. The product code is KGN; no regulation number or medical specialty code has been assigned. This device is an implant.
510(k)s
156
FEI Numbers
122
Registration Numbers
122
Unique Applicants
98
Years Active
46
Basic Information
- Product Code
- KGN
- Device Class
- FDA unclassified
- Medical Specialty
- Unknown
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✓
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
Unclassified Reason
1
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 156 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K250329 | GeniPhys Collymer Self-Assembling Scaffold | Jun 25, 2025 | Substantially Equivalent | GeniPhys, Inc. |
| K242985 | CollOvine Wound Dressing | Jun 20, 2025 | Substantially Equivalent | OviGenex LLC |
| K241904 | DermiSphere Dermal Template | Jan 06, 2025 | Substantially Equivalent | FesariusTherapeutics Inc. |
| K243071 | Bovine Dermis Collagen Dermal Matrix | Dec 19, 2024 | Substantially Equivalent | Collagen Matrix, Inc. |
| K242146 | BIOBRANE Temporary Wound Dressing; BIOBRANE Glove | Dec 17, 2024 | Substantially Equivalent | Smith & Nephew Medical Limited |
| K242828 | Corplex P/ Theracor P/ Allacor P | Oct 18, 2024 | Substantially Equivalent | StimLabs, LLC |
| K233378 | ABCcolla® Collagen ADM Scaffold | Oct 18, 2024 | Substantially Equivalent | ACRO Biomedical Co., Ltd. |
| K241080 | Kerecis Parvus (50207) | Aug 21, 2024 | Substantially Equivalent | Kerecis Limited |
| K241866 | InnovaMatrix®FD | Jul 26, 2024 | Substantially Equivalent | Convatec Triad Life Sciences, LLC |
| K241724 | Cytal® Wound Matrix; Cytal® Burn Matrix | Jul 11, 2024 | Substantially Equivalent | ACell, Inc |
| K241706 | MicroMatrix® UBM Particulate | Jul 11, 2024 | Substantially Equivalent | ACell, Inc |
| K232796 | LUOFUCON® Collagen Particles (Collagen Wound Dressing) | Apr 25, 2024 | Substantially Equivalent | Huizhou Foryou Medical Devices Co., Ltd. |
| K240753 | Miro3D Fibers Wound Matrix | Apr 19, 2024 | Substantially Equivalent | Reprise Biomedical, Inc. |
| K232204 | ReyaGel (RG03 - MTP gel 3mL) | Apr 19, 2024 | Substantially Equivalent | FetTech |
| K240277 | MiroDry Wound Matrix | Mar 01, 2024 | Substantially Equivalent | Reprise Biomedical, Inc. |
| K231325 | Corplex P / Theracor P / Allacor P | Feb 02, 2024 | Substantially Equivalent | StimLabs, LLC |
| K231614 | MiroTract Wound Matrix | Dec 13, 2023 | Substantially Equivalent | Reprise Biomedical, Inc. |
| K232758 | Comatryx OTC | Dec 01, 2023 | Substantially Equivalent | Strukmyer Medical, LLC. |
| K231152 | Collagen Wound Dressing | Oct 12, 2023 | Substantially Equivalent | Winner Medical Co., Ltd. |
| K223126 | SurgiAid® Collagen Wound Dressing | Oct 11, 2023 | Substantially Equivalent | Maxigen Biotech, Inc. |
| K230980 | MicroMatrix® Flex | Sep 22, 2023 | Substantially Equivalent | ACell, Inc. |
| K220498 | NovoGen Wound Matrix | Jun 09, 2023 | Substantially Equivalent | Novabone Products, LLC |
| K212579 | FortiShield (Biosynthetic Wound Matrix) | May 02, 2023 | Substantially Equivalent | Organogenesis Inc. |
| K223257 | Miro3D Wound Matrix | Nov 21, 2022 | Substantially Equivalent | Reprise Biomedical |
| K213716 | InnovaBurn | Sep 29, 2022 | Substantially Equivalent | Triad Life Sciences, Inc. |
| K211902 | InnovaMatrix PD | Sep 28, 2022 | Substantially Equivalent | Triad Life Sciences, Inc. |
| K213598 | LUOFUCON Collagen Wound Dressing | Sep 20, 2022 | Substantially Equivalent | Huizhou Foryou Medical Devices CO., Ltd. |
| K221520 | Miro3D Wound Matrix | Aug 18, 2022 | Substantially Equivalent | Reprise Biomedical, Inc. |
| K213498 | PELNAC Meshed Bilayer Wound Matrix | Jul 14, 2022 | Substantially Equivalent | Gunze Limited |
| K220317 | PuraPly Micronized Wound Matrix (PuraPly MZ) | Jul 01, 2022 | Substantially Equivalent | Organogenesis Inc. |
| K213231 | Kerecis Silicone | Jun 29, 2022 | Substantially Equivalent | Kerecis Limited |
| K213341 | Fibrillar Collagen Wound Dressing | May 31, 2022 | Substantially Equivalent | Collagen Matrix, Inc. |
| K213607 | Geistlich Wound Matrix PLUS | Apr 28, 2022 | Substantially Equivalent | Geistlich Pharma AG |
| K213573 | PELNAC Wound Matrix | Feb 09, 2022 | Substantially Equivalent | Gunze Limited |
| K213092 | Cellusheet, Cellufil | Dec 15, 2021 | Substantially Equivalent | Human Biosciences, Inc. |
| K210128 | INTEGRA Wound Matrix (Macro-Channels) | Oct 08, 2021 | Substantially Equivalent | Integra LifeSciences Corporation |
| K210024 | NeoMatriX Wound Matrix | Oct 07, 2021 | Substantially Equivalent | NeXtGen Biologics, Inc. |
| K210580 | InnovaMatrix FS | Apr 21, 2021 | Substantially Equivalent | Triad Life Sciences, Inc. |
| K200502 | Myriad Particles | Mar 31, 2021 | Substantially Equivalent | Aroa Biosurgery Ltd. |
| K201577 | MatriDerm | Jan 07, 2021 | Substantially Equivalent | MedSkin Solutions Dr. Suwelack AG |
| K193552 | InnovaMatrix | Oct 21, 2020 | Substantially Equivalent | Triad Life Sciences, Inc. |
| K200413 | Symphony | Jul 29, 2020 | Substantially Equivalent | Aroa Biosurgery Ltd. |
| K192386 | KeraStat Cream | Jul 16, 2020 | Substantially Equivalent | KeraNetics |
| K191992 | PELNAC Bilayer Wound Matrix | Apr 29, 2020 | Substantially Equivalent | Gunze Limited |
| K192346 | scaffolene CL100 Bioresorbable Collagen Matrix | Feb 28, 2020 | Substantially Equivalent | Freudenberg Technology Innovation SE & Co. KG |
| K192725 | Cytal Wound Matrix 3-Layer | Oct 25, 2019 | Substantially Equivalent | ACell, Inc. |
| K190528 | MariGen Wound Extra | Jul 10, 2019 | Substantially Equivalent | Kerecis Limited |
| K182010 | ProgenaMatrix | Jan 17, 2019 | Substantially Equivalent | Cell Constructs I, LLC |
| K182838 | Geistlich Derma-Gide | Nov 08, 2018 | Substantially Equivalent | Geistlich Pharma AG |
| K181330 | NeoMatriX Wound Matrix | Oct 11, 2018 | Substantially Equivalent | NeXtGen Biologics, Inc. |
| K180776 | Cytal Wound Particulate | May 11, 2018 | Substantially Equivalent | ACell, Inc. |
| K172593 | XCelliStem Wound Powder | Mar 16, 2018 | Substantially Equivalent | StemSys |
| K173223 | ologen Collagen Matrix | Mar 02, 2018 | Substantially Equivalent | Aeon Astron Europe B.V. |
| K171842 | Geistlich Wound Matrix | Nov 03, 2017 | Substantially Equivalent | Geistlich Pharma AG |
| K172399 | MicroMatrix | Oct 06, 2017 | Substantially Equivalent | ACell, Inc. |
| K171645 | CoMatryx Collagen Wound Dressing 1 gram pouch, CoMatryx Collagen Wound Dressing 1 gram vial, CoMatryx Collagen Wound Dressing 10 gram bottle | Jul 25, 2017 | Substantially Equivalent | Strukmyer Medical |
| K171231 | Endoform Topical Matrix | Jun 14, 2017 | Substantially Equivalent | Aroa Biosurgery |
| K162759 | KeraStat(R) Gel | Jun 02, 2017 | Substantially Equivalent | KeraNetics, LLC. |
| K162348 | ABCcolla Collagen Matrix | May 10, 2017 | Substantially Equivalent | ACRO BIOMEDICAL CO., LTD |
| K160136 | Flowable Wound Matrix | Sep 28, 2016 | Substantially Equivalent | COOK BIOTECH INCORPORATED |
| K152600 | Collagen Dental Wound Dressings | Jun 23, 2016 | Substantially Equivalent | COLLAGEN MATRIX, INC. |
| K153754 | MicroMatrix | Mar 14, 2016 | Substantially Equivalent | ACELL, INC |
| K153690 | PriMatrix Dermal Repair Scaffold | Feb 22, 2016 | Substantially Equivalent | TEI BioSciences Inc. |
| K152721 | Cytal Wound Matrix | Dec 08, 2015 | Substantially Equivalent | ACELL, INC |
| K152033 | Cook ECM Powder | Aug 19, 2015 | Substantially Equivalent | Cook Biotech Incorporated |
| K140820 | XENOMEM WOUND MATRIX | Jun 26, 2015 | Substantially Equivalent | VISCUS BIOLOGICS LLC |
| K141738 | MEDEOR MATRIX WOUND DRESSING | Feb 17, 2015 | Substantially Equivalent | KENSEY NASH CORPORATION DBA DSM BIOMEDICAL |
| K143426 | Wound Matrix TF | Jan 27, 2015 | Substantially Equivalent | MIROMATRIX MEDICAL INC. |
| K142712 | Dental Collagen Wound Dressing (Nova Tape and NovaPlug) | Jan 08, 2015 | Substantially Equivalent | NovaBone Products, LLC |
| K140367 | ARCHITECT PX EXTRACELLULAR COLLAGEN MATRIX | Sep 12, 2014 | Substantially Equivalent | HARBOR MEDTECH, INC. |
| K134037 | PREMVIA | Aug 07, 2014 | Substantially Equivalent | BIOTIME, INC. |
| K140456 | BIO-CONNEKT WOUND MATRIX | Jul 22, 2014 | Substantially Equivalent | MLM BIOLOGICS, INC. |
| K140510 | MIROMATRIX WOUND MATRIX | Jun 19, 2014 | Substantially Equivalent | MIROMATRIX MEDICAL INC. |
| K133290 | COLLACARE DENTAL | May 01, 2014 | Substantially Equivalent | INNOCOLL PHARMACEUTICALS |
| K132343 | MARIGEN WOUND DRESSING | Oct 23, 2013 | Substantially Equivalent | KERECIS LIMITED |
| K123756 | COVAGEN | Aug 16, 2013 | Substantially Equivalent | COVALON TECHNOLOGIES LTD. |
| K131286 | PRIMATRIX DERMAL REPAIR SCAFFOLD | Aug 05, 2013 | Substantially Equivalent | TEI BIOSCIENCES INC. |
| K120250 | FIBRILLAR COLLAGEN WOUND DRESSING | Apr 21, 2013 | Substantially Equivalent | COLLAFIRM LLC |
| K122502 | BRIDGE EXTRACELLULAR COLLEGEN MATRIX | Feb 26, 2013 | Substantially Equivalent | HARBOR MEDTECH, INC. |
| K122115 | COLLAGEN DENTAL WOUND DRESSINGS | Nov 01, 2012 | Substantially Equivalent | COLLAGEN MATRIX, INC. |
| K122325 | SKINTEMP II | Oct 26, 2012 | Substantially Equivalent | HUMAN BIOSCIENCES, INC. |
| K120339 | PROCOLL | Jun 21, 2012 | Substantially Equivalent | INNOCOLL PHARMACEUTICALS |
| K112580 | COLLAGEN WOUND DRESSING | Jun 01, 2012 | Substantially Equivalent | DALIM TISSEN CO., LTD. |
| K113866 | PORCINE DERMAL XENOGRAFTS PORCINE DERMAL MATRIX | Mar 23, 2012 | Substantially Equivalent | BRENNEN MEDICAL, LLC |
| K112888 | MESO WOUND MATRIX | Feb 10, 2012 | Substantially Equivalent | KENSEY NASH CORPORATION |
| K113104 | INTEGRA WOUND MATRIX (THIN) | Feb 09, 2012 | Substantially Equivalent | INTEGRA LIFESCIENCES CORPORATION |
| K110318 | EXCELLAGEN | Oct 03, 2011 | Substantially Equivalent | TISSUE REPAIR COMPANY |
| K103648 | COLLAGEN POWDER | Sep 14, 2011 | Substantially Equivalent | INNOCOLL PHARMACEUTICALS LTD |
| K112399 | UNITE BIOMATRIX | Sep 07, 2011 | Substantially Equivalent | SYNOVIS ORTHOPEDIC & WOUNDCARE |
| K112409 | MATRISTEM WOUND MATRIX | Aug 29, 2011 | Substantially Equivalent | ACELL, INC |
| K110388 | COLLACARE DENTAL | Aug 09, 2011 | Substantially Equivalent | INNOCOLL PHARMACEUTICALS LTD |
| K102946 | CORELEADER COLLA-PAD MODEL CS 03030 | May 20, 2011 | Substantially Equivalent | CORELEADER BIOTECH CO., LTD. |
| K100927 | SURGIAID | Feb 02, 2011 | Substantially Equivalent | MAXIGEN BIOTECH, INC. |
| K100574 | COLLEXA | Oct 28, 2010 | Substantially Equivalent | INNOCOLL PHARMACEUTICALS |
| K101546 | ENDOFORM DENTAL TEMPLATE | Jun 23, 2010 | Substantially Equivalent | MESYNTHES LTD |
| K092805 | COLLAGEN SPONGE | Feb 16, 2010 | Substantially Equivalent | INNOCOLL PHARMACEUTICALS |
| K092096 | ENDOFORM DERMAL TEMPLATE | Jan 21, 2010 | Substantially Equivalent | MESYNTHES LTD |
| K092926 | ACELL MATRISTEM WOUND SHEET | Oct 28, 2009 | Substantially Equivalent | ACELL, INC |
| K091338 | COLLASORB COLLAGEN WOUND DRESSING | Aug 26, 2009 | Substantially Equivalent | HARTMANN-CONCO INC. |
| K090954 | ATLAS WOUND MATRIX | Jul 30, 2009 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K090812 | THERAFORM STANDARD/SHEET | Jul 30, 2009 | Substantially Equivalent | SEWON CELLONTECH CO., LTD. |
| K080868 | AONGEN COLLAGEN MATRIX | May 14, 2009 | Substantially Equivalent | AEON ASTRON EUROPE B.V. |
| K082869 | AWBAT-S, AWBAT-D, AWBAT-M | Feb 06, 2009 | Substantially Equivalent | AUBREY, INC. |
| K083440 | PRIMATRIX DERMAL REPAIR SCAFFOLD | Dec 12, 2008 | Substantially Equivalent | TEI BIOSCIENCES INC. |
| K081635 | INTEGRA MESHED BILAYER WOUND MATRIX | Dec 04, 2008 | Substantially Equivalent | INTEGRA LIFESCIENCES CORP. |
| K081724 | HYDROLYZED COLLAGEN WITH 10% CHONDROITIN SULFATE (PSGAG, POLYSULFATED GLYCOSAMINOGLYCAN) WOUND GEL | Oct 30, 2008 | Substantially Equivalent | APPLIED NUTRITIONALS |
| K082103 | LTM WOUND DRESSING | Oct 08, 2008 | Substantially Equivalent | LIFECELL CORP. |
| K081782 | COLLIEVA | Sep 30, 2008 | Substantially Equivalent | INNOCOLL PHARMACEUTICALS |
| K072113 | INTEGRA FLOWABLE WOUND MATRIX, MODEL FWD301 | Oct 10, 2007 | Substantially Equivalent | INTEGRA LIFESCIENCES CORP. |
| K071425 | UNITE BIOMATRIX | Jun 20, 2007 | Substantially Equivalent | PEGASUS BIOLOGICS, INC. |
| K070269 | MODIFICATION TO COLLAWOUND DRESSING | Mar 02, 2007 | Substantially Equivalent | COLLAMATRIX CO., INC. |
| K061746 | COLLAGUARD, MODEL FCIA,FCIB,FCIC,AND FCID | Oct 02, 2006 | Substantially Equivalent | INNOCOLL PHARMACEUTICALS |
| K061494 | DERMADAPT WOUND DRESSING | Sep 21, 2006 | Substantially Equivalent | PEGASUS BIOLOGICS, INC. |
| K061711 | OASIS WOUND MATRIX | Jul 19, 2006 | Substantially Equivalent | COOK BIOTECH, INC. |
| K061474 | COLLAWOUND DRESSING | Jul 05, 2006 | Substantially Equivalent | COLLAMATRIX CO., INC. |
| K061407 | PRIMATRIX DERMAL REPAIR SCAFFOLD | Jun 29, 2006 | Substantially Equivalent | TEI BIOSCIENCES INC. |
| K060888 | ACELL POWDER WOUND DRESSING | Jun 23, 2006 | Substantially Equivalent | ACELL, INC |
| K060456 | MEDLINE COLLAGEN WOUND DRESSING | Jun 19, 2006 | Substantially Equivalent | MEDLINE INDUSTRIES, INC. |
| K050177 | COLACTIVE COLLAGEN WOUND DRESSING | Apr 27, 2005 | Substantially Equivalent | COVALON TECHNOLOGIES, INC. |
| K040314 | HEALICOLL | Aug 12, 2004 | Substantially Equivalent | ENCOLL CORP. |
| K030774 | STIMULEN COLLAGEN | Aug 09, 2004 | Substantially Equivalent | SOUTHWEST TECHNOLOGIES, INC. |
| K040403 | COLLAGEN WOUND DRESSING - ORAL | May 10, 2004 | Substantially Equivalent | COLLAGEN MATRIX, INC. |
| K040558 | MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING | Mar 17, 2004 | Substantially Equivalent | COLLAGEN MATRIX, INC. |
| K040211 | MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING | Feb 27, 2004 | Substantially Equivalent | COLLAGEN MATRIX, INC. |
| K023778 | DRESSSKIN | Sep 29, 2003 | Substantially Equivalent | TEI BIOSCIENCES INC. |
| K030921 | COLLAGEN TOPICAL WOUND DRESSING | May 15, 2003 | Substantially Equivalent | COLLAGEN MATRIX, INC. |
| K022854 | ACELL UBM HYDRATED WOUND DRESSING | Dec 30, 2002 | Substantially Equivalent | ACELL, INC |
| K021637 | ACELL UBM LYOPHILIZED WOUND DRESSING | Dec 19, 2002 | Substantially Equivalent | ACELL, INC |
| K022127 | AVAGEN WOUND DRESSING | Sep 10, 2002 | Substantially Equivalent | INTEGRA LIFESCIENCES CORP. |
| K021792 | BILAYER MATRIX WOUND DRESSING | Aug 14, 2002 | Substantially Equivalent | INTEGRA LIFESCIENCES CORP. |
| K020732 | SS MATRIX | May 30, 2002 | Substantially Equivalent | COOK BIOTECH, INC. |
| K012990 | COLLATEK POWDER | Oct 24, 2001 | Substantially Equivalent | BIOCORE MEDICAL TECHNOLOGIES, INC. |
| K011026 | FORTADERM WOUND DRESSING | Jun 13, 2001 | Substantially Equivalent | ORGANOGENESIS, INC. |
| K003134 | FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING | Dec 22, 2000 | Substantially Equivalent | ADRI/TECHNAM |
| K002443 | COLLAGEN WOUND DRESSING | Oct 18, 2000 | Substantially Equivalent | OASIS RESEARCH, LLC. |
| K000487 | MEDTRADE PRODUCTS ALGINATE ISLAND | Apr 18, 2000 | Substantially Equivalent | MEDTRADE PRODUCTS LTD. |
| K994339 | HYCURE ORAL / HYCURE ORAL SMART GEL | Mar 22, 2000 | Substantially Equivalent | THE HYMED GROUP CORP. |
| K000054 | FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING WITH COLLAGEN | Mar 13, 2000 | Substantially Equivalent | ADRI |
| K993948 | SIS WOUND DRESSING II | Jan 06, 2000 | Substantially Equivalent | COOK BIOTECH, INC. |
| K990964 | SIGNADRESS DUODERM DRESSING | May 18, 1999 | Substantially Equivalent | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
| K984388 | HA ABSORBENT WOUND DRESSING | Mar 03, 1999 | Substantially Equivalent | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
| K982597 | FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATE | Aug 20, 1998 | Substantially Equivalent | JOHNSON & JOHNSON MEDICAL, INC. |
| K973170 | SIS WOUND DRESSING | Apr 30, 1998 | Substantially Equivalent | COOK BIOTECH, INC. |
| K970266 | KENDALL HYDROPHILIC POWDER WOUND DRESSING | Apr 23, 1997 | Substantially Equivalent for Some Indications | KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH |
| K963228 | REPLIDERM WOUND DRESSING | Dec 18, 1996 | Substantially Equivalent for Some Indications | ORPHAN MEDICAL, INC. |
| K955506 | HYCURE | Jan 17, 1996 | Substantially Equivalent | THE HYMED GROUP CORP. |
| K950032 | MEDISKIN(R) SS, ZENODERM BIOLOGICAL WOUND DRESSING | Jun 28, 1995 | Substantially Equivalent | BRENNEN MEDICAL, INC. |
| K950281 | MESH MATRIX WOUND DRESSING | Apr 13, 1995 | Substantially Equivalent | BRENNEN MEDICAL, INC. |
| K935189 | E-Z DERM BIOSYNTHETIC WOUND DRESSING | Jul 11, 1994 | Substantially Equivalent for Some Indications | BRENNEN MEDICAL, INC. |
| K925545 | SKINTEMP, MODIFICATION | Feb 23, 1993 | Substantially Equivalent | BIOCORE |
| K914024 | VIADERM | Dec 04, 1991 | Substantially Equivalent | ABS LIFE SCIENCES |
| K913023 | SKINTEMP | Oct 02, 1991 | Substantially Equivalent | BIOCORE |
| K910944 | MEDIFIL | Apr 02, 1991 | Substantially Equivalent | BIOCORE |
| K893647 | COPOLYESTER FILM DRESSING | Oct 16, 1989 | Substantially Equivalent | TRI-STATE HOSPITAL SUPPLY CORP. |
| K843788 | CUSTOM BURN DRESSING KIT | Nov 07, 1984 | Substantially Equivalent | HERMITAGE HOSPITAL PRODUCTS, INC. |
| K790496 | BIOBRANE BRAND TEMPORARY WOUND DRESSING | May 03, 1979 | Substantially Equivalent | WOODROOF LABORATORIES, INC. |
FEI Numbers
This FDA classification entry is associated with 122 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 122 registration numbers. Click on an entry to view related FDA registrations.