Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- MiscellaneousMiscellaneous
- MVFSystem, Laser, Photodynamic Therapy3Product Code
- MVGSystem, Laser, Fiber Optic, Photodynamic Therapy3Product Code
- MWZExpander, Breast, ExternalUProduct Code
- MYHSystem, Non-Coherent Light, Photodynamic Therapy3Product Code
- NBESealant, Polymerizing3Product Code
- PBDComposite Cultured SkinFProduct Code
- QPEPhototherapy Device For Reducing The Appearance Of Acute Post-Surgical Incisions2Product Code
- MTJWax, BoneUProduct Code
- DTHSuture, Cardiovascular3Product Code
- DZGSuture, Dental3Product Code
- EFQGauze/Sponge, InternalUProduct Code
- EYFProtector, Wound, PlasticUProduct Code
- FRODressing, Wound, DrugUProduct Code
- GELGauze/Sponge, Internal, With Drug/Biologic, Animal Source MaterialUProduct Code
- GERGauze, External (With Drug/Biologic/Animal Source Material)UProduct Code
- HMNSuture, Nonabsorable, Ophthalmic3Product Code
- HMOSuture, Absorbable, Ophthalmic3Product Code
- KGMSilicone, Liquid, Injectable3Product Code
- KGNDressing, Wound, CollagenUProduct Code
- K242100SurgiAid Collagen Wound Dressing (HA)UCleared 510(K)
- K252001Collagen Wound DressingUCleared 510(K)
- K250397Helios Dermal ScaffoldUCleared 510(K)
- K251845Marigen Wound Extra; Kerecis Silicone; Kerecis ParvusUCleared 510(K)
- K250329GeniPhys Collymer Self-Assembling ScaffoldUCleared 510(K)
- K242985CollOvine™ Wound DressingUCleared 510(K)
- K241904DermiSphere Dermal TemplateUCleared 510(K)
- K243071Bovine Dermis Collagen Dermal MatrixUCleared 510(K)
- K242146BIOBRANE Temporary Wound Dressing; BIOBRANE GloveUCleared 510(K)
- K242828Corplex P/ Theracor P/ Allacor PUCleared 510(K)
- K233378ABCcolla® Collagen ADM ScaffoldUCleared 510(K)
- K241080Kerecis Parvus (50207)UCleared 510(K)
- K241866InnovaMatrix®FDUCleared 510(K)
- K241724Cytal® Wound Matrix; Cytal® Burn MatrixUCleared 510(K)
- K241706MicroMatrix® UBM ParticulateUCleared 510(K)
- K232796LUOFUCON® Collagen Particles (Collagen Wound Dressing)UCleared 510(K)
- K240753Miro3D Fibers Wound MatrixUCleared 510(K)
- K232204ReyaGel (RG03 - MTP gel 3mL)UCleared 510(K)
- K240277MiroDry Wound MatrixUCleared 510(K)
- K231325Corplex P / Theracor P / Allacor PUCleared 510(K)
- K231614MiroTract Wound MatrixUCleared 510(K)
- K232758Comatryx OTCUCleared 510(K)
- K231152Collagen Wound DressingUCleared 510(K)
- K223126SurgiAid® Collagen Wound DressingUCleared 510(K)
- K230980MicroMatrix® FlexUCleared 510(K)
- K220498NovoGen Wound MatrixUCleared 510(K)
- K212579FortiShield (Biosynthetic Wound Matrix)UCleared 510(K)
- K223257Miro3D Wound MatrixUCleared 510(K)
- K213716InnovaBurnUCleared 510(K)
- K211902InnovaMatrix PDUCleared 510(K)
- K213598LUOFUCON Collagen Wound DressingUCleared 510(K)
- K221520Miro3D Wound MatrixUCleared 510(K)
- K213498PELNAC Meshed Bilayer Wound MatrixUCleared 510(K)
- K220317PuraPly Micronized Wound Matrix (PuraPly MZ)UCleared 510(K)
- K213231Kerecis SiliconeUCleared 510(K)
- K213341Fibrillar Collagen Wound DressingUCleared 510(K)
- K213607Geistlich Wound Matrix PLUSUCleared 510(K)
- K213573PELNAC Wound MatrixUCleared 510(K)
- K213092Cellusheet, CellufilUCleared 510(K)
- K210128INTEGRA Wound Matrix (Macro-Channels)UCleared 510(K)
- K210024NeoMatriX Wound MatrixUCleared 510(K)
- K210580InnovaMatrix FSUCleared 510(K)
- K200502Myriad ParticlesUCleared 510(K)
- K201577MatriDermUCleared 510(K)
- K193552InnovaMatrixUCleared 510(K)
- K200413SymphonyUCleared 510(K)
- K192386KeraStat CreamUCleared 510(K)
- K191992PELNAC Bilayer Wound MatrixUCleared 510(K)
- K192346scaffolene CL100 Bioresorbable Collagen MatrixUCleared 510(K)
- K192725Cytal Wound Matrix 3-LayerUCleared 510(K)
- K190528MariGen Wound ExtraUCleared 510(K)
- K182010ProgenaMatrixUCleared 510(K)
- K182838Geistlich Derma-GideUCleared 510(K)
- K181330NeoMatriX Wound MatrixUCleared 510(K)
- K180776Cytal Wound ParticulateUCleared 510(K)
- K172593XCelliStem Wound PowderUCleared 510(K)
- K173223ologen Collagen MatrixUCleared 510(K)
- K171842Geistlich Wound MatrixUCleared 510(K)
- K172399MicroMatrixUCleared 510(K)
- K171645CoMatryx Collagen Wound Dressing 1 gram pouch, CoMatryx Collagen Wound Dressing 1 gram vial, CoMatryx Collagen Wound Dressing 10 gram bottleUCleared 510(K)
- K171231Endoform Topical MatrixUCleared 510(K)
- K162759KeraStat(R) GelUCleared 510(K)
- K162348ABCcolla Collagen MatrixUCleared 510(K)
- K160136Flowable Wound MatrixUCleared 510(K)
- K152600Collagen Dental Wound DressingsUCleared 510(K)
- K153754MicroMatrixUCleared 510(K)
- K153690PriMatrix Dermal Repair ScaffoldUCleared 510(K)
- K152721Cytal Wound MatrixUCleared 510(K)
- K152033Cook ECM PowderUCleared 510(K)
- K140820XENOMEM WOUND MATRIXUCleared 510(K)
- K141738MEDEOR MATRIX WOUND DRESSINGUCleared 510(K)
- K143426Wound Matrix TFUCleared 510(K)
- K142712Dental Collagen Wound Dressing (Nova Tape and NovaPlug)UCleared 510(K)
- K140367ARCHITECT PX EXTRACELLULAR COLLAGEN MATRIXUCleared 510(K)
- K134037PREMVIAUCleared 510(K)
- K140456BIO-CONNEKT WOUND MATRIXUCleared 510(K)
- K140510MIROMATRIX WOUND MATRIXUCleared 510(K)
- K133290COLLACARE DENTALUCleared 510(K)
- K132343MARIGEN WOUND DRESSINGUCleared 510(K)
- K123756COVAGENUCleared 510(K)
- K131286PRIMATRIX DERMAL REPAIR SCAFFOLDUCleared 510(K)
- K120250FIBRILLAR COLLAGEN WOUND DRESSINGUCleared 510(K)
- K122502BRIDGE EXTRACELLULAR COLLEGEN MATRIXUCleared 510(K)
- K122115COLLAGEN DENTAL WOUND DRESSINGSUCleared 510(K)
- K122325SKINTEMP IIUCleared 510(K)
- K120339PROCOLLUCleared 510(K)
- K112580COLLAGEN WOUND DRESSINGUCleared 510(K)
- K113866PORCINE DERMAL XENOGRAFTS PORCINE DERMAL MATRIXUCleared 510(K)
- K112888MESO WOUND MATRIXUCleared 510(K)
- K113104INTEGRA WOUND MATRIX (THIN)UCleared 510(K)
- K110318EXCELLAGENUCleared 510(K)
- K103648COLLAGEN POWDERUCleared 510(K)
- K112399UNITE BIOMATRIXUCleared 510(K)
- K112409MATRISTEM WOUND MATRIXUCleared 510(K)
- K110388COLLACARE DENTALUCleared 510(K)
- K102946CORELEADER COLLA-PAD MODEL CS 03030UCleared 510(K)
- K100927SURGIAIDUCleared 510(K)
- K100574COLLEXAUCleared 510(K)
- K101546ENDOFORM DENTAL TEMPLATEUCleared 510(K)
- K092805COLLAGEN SPONGEUCleared 510(K)
- K092096ENDOFORM DERMAL TEMPLATEUCleared 510(K)
- K092926ACELL MATRISTEM WOUND SHEETUCleared 510(K)
- K090823THERAFORM BILAYERUCleared 510(K)
- K091338COLLASORB COLLAGEN WOUND DRESSINGUCleared 510(K)
- K090954ATLAS WOUND MATRIXUCleared 510(K)
- K090812THERAFORM STANDARD/SHEETUCleared 510(K)
- K090894COLLAWOUND WOUND DRESSINGUCleared 510(K)
- K080868AONGEN COLLAGEN MATRIXUCleared 510(K)
- K082869AWBAT-S, AWBAT-D, AWBAT-MUCleared 510(K)
- K083440PRIMATRIX DERMAL REPAIR SCAFFOLDUCleared 510(K)
- K081635INTEGRA MESHED BILAYER WOUND MATRIXUCleared 510(K)
- K081724HYDROLYZED COLLAGEN WITH 10% CHONDROITIN SULFATE (PSGAG, POLYSULFATED GLYCOSAMINOGLYCAN) WOUND GELUCleared 510(K)
- K082103LTM WOUND DRESSINGUCleared 510(K)
- K081782COLLIEVAUCleared 510(K)
- K072113INTEGRA FLOWABLE WOUND MATRIX, MODEL FWD301UCleared 510(K)
- K071425UNITE BIOMATRIXUCleared 510(K)
- K070269MODIFICATION TO COLLAWOUND DRESSINGUCleared 510(K)
- K061746COLLAGUARD, MODEL FCIA,FCIB,FCIC,AND FCIDUCleared 510(K)
- K061494DERMADAPT WOUND DRESSINGUCleared 510(K)
- K061711OASIS WOUND MATRIXUCleared 510(K)
- K061474COLLAWOUND DRESSINGUCleared 510(K)
- K061407PRIMATRIX DERMAL REPAIR SCAFFOLDUCleared 510(K)
- K060888ACELL POWDER WOUND DRESSINGUCleared 510(K)
- K060456MEDLINE COLLAGEN WOUND DRESSINGUCleared 510(K)
- K050177COLACTIVE COLLAGEN WOUND DRESSINGUCleared 510(K)
- K040314HEALICOLLUCleared 510(K)
- K030774STIMULEN COLLAGENUCleared 510(K)
- K040403COLLAGEN WOUND DRESSING - ORALUCleared 510(K)
- K040558MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSINGUCleared 510(K)
- K040211MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSINGUCleared 510(K)
- K023778DRESSSKINUCleared 510(K)
- K030921COLLAGEN TOPICAL WOUND DRESSINGUCleared 510(K)
- K022854ACELL UBM HYDRATED WOUND DRESSINGUCleared 510(K)
- K021637ACELL UBM LYOPHILIZED WOUND DRESSINGUCleared 510(K)
- K022127AVAGEN WOUND DRESSINGUCleared 510(K)
- K021792BILAYER MATRIX WOUND DRESSINGUCleared 510(K)
- K020732SS MATRIXUCleared 510(K)
- K014129PROMOGRAN MATRIX WOUND DRESSINGUCleared 510(K)
- K012990COLLATEK POWDERUCleared 510(K)
- K011026FORTADERM WOUND DRESSINGUCleared 510(K)
- K003134FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSINGUCleared 510(K)
- K002443COLLAGEN WOUND DRESSINGUCleared 510(K)
- K000487MEDTRADE PRODUCTS ALGINATE ISLANDUCleared 510(K)
- K994339HYCURE ORAL / HYCURE ORAL SMART GELUCleared 510(K)
- K000054FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING WITH COLLAGENUCleared 510(K)
- K993948SIS WOUND DRESSING IIUCleared 510(K)
- K990964SIGNADRESS DUODERM DRESSINGUCleared 510(K)
- K984388HA ABSORBENT WOUND DRESSINGUCleared 510(K)
- K982597FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATEUCleared 510(K)
- K973170SIS WOUND DRESSINGUCleared 510(K)
- K970266KENDALL HYDROPHILIC POWDER WOUND DRESSINGUCleared 510(K)
- K963228REPLIDERM WOUND DRESSINGUCleared 510(K)
- K955506HYCUREUCleared 510(K)
- K950032MEDISKIN(R) SS, ZENODERM BIOLOGICAL WOUND DRESSINGUCleared 510(K)
- K950281MESH MATRIX WOUND DRESSINGUCleared 510(K)
- K935189E-Z DERM BIOSYNTHETIC WOUND DRESSINGUCleared 510(K)
- K925545SKINTEMP, MODIFICATIONUCleared 510(K)
- K914024VIADERMUCleared 510(K)
- K913023SKINTEMPUCleared 510(K)
- K910944MEDIFILUCleared 510(K)
- K893647COPOLYESTER FILM DRESSINGUCleared 510(K)
- K843788CUSTOM BURN DRESSING KITUCleared 510(K)
- K790496BIOBRANE BRAND TEMPORARY WOUND DRESSINGUCleared 510(K)
- LCJExpander, Skin, InflatableUProduct Code
- LFLInstrument, Ultrasonic SurgicalUProduct Code
- LMHImplant, Dermal, For Aesthetic Use3Product Code
- LMIImplant, Collagen For Non-Aesthetic Use3Product Code
- LRQTracheostomy And Nasal Suctioning Kit1Product Code
- LRRFirst Aid Kit With DrugNProduct Code
- LXULaser For Wound Healing3Product Code
- MAWMarker, Suture IdentificationUProduct Code
- MDDDevice, Dermal Replacement3Product Code
- MGPDressing, Wound And Burn, OcclusiveUProduct Code
- MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or BiologicUProduct Code
- MGRDressing, Wound And Burn, Interactive3Product Code
- MQZProsthesis, NailUProduct Code
- MRDSizer, Mammary, Breast Implant VolumeUProduct Code
- MSADressing, Wound And Burn, Occlusive, HeatedUProduct Code
- NLQScalpel, Ultrasonic, ReprocessedUProduct Code
- NQKMaggots, MedicalUProduct Code
- NRNLeeches, MedicinalUProduct Code
- NSSElectronic Media, NauseaNProduct Code
- NZFStatic Electricity-Emitting Device, Cosmetic UseNProduct Code
- OCECultured Epithelial AutograftFProduct Code
- ODSWound Covering (Composite Cultured Skin)FProduct Code
- OEEDiagnostic Low Electric Field3Product Code
- OJIBurn Kit With DrugNProduct Code
- ONVElectrical Impedance Spectrometer3Product Code
- OYDOptical Diagnostic Device For Melanoma Detection3Product Code
- PFCCultured Human Cell Skin Dressing3Product Code
- PHUIntra-Abdominal Pressure Monitoring DeviceUProduct Code
- PKYImplant, Dermal, For Aesthetic Use In The Hands3Product Code
- PUVLymph Node Location System During Sentinel Biopsy Procedure3Product Code
- PZCAblation System, High Intensity Focus Ultrasound (Hifu), Soft TissueNProduct Code
- QOJApparatus, Suction, Operating-Room, Wall Vacuum Powered (Export Only)NProduct Code
- QQFSkin Microneedling Manual/Automated Device (Export Only)NProduct Code
- QVSBreast Implant Suction Retrieval Device2Product Code
- QVXSkin Patch For Treatment Of Hyperhidrosis2Product Code
- PLJTissue Adhesive Internal Use3Product Code
- QSXHemostatic Wound Dressing With Thrombin Or Other BiologicsUProduct Code
- QSYHemostatic Wound Dressing Without Thrombin Or Other BiologicsUProduct Code
- QSZAbsorbable Synthetic Wound DressingUProduct Code
- QGMFocused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation2Product Code
- QZSSoftware-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer2Product Code
- SABTable Mounted Miniaturized Electromechanical Surgical System2Product Code
- SAQElectromechanical System For Open Microsurgery2Product Code
- SAWFluorescence Imaging For Breast Cancer Detection3Product Code
- QMLAnal Fistula Closure Device2Product Code
- SAHMagnetic Compression Anastomosis System2Product Code
- QYKSemi-Automated Autologous Skin Graft Harvesting And Application Device2Product Code
- SCVModular Electromechanical Surgical System2Product Code
- SDDElectromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field2Product Code
- SEJWound Dressings Containing Topical AnalgesicsUProduct Code
- SEKWound Dressings With HydrocortisoneUProduct Code
- SELSecurement Wound Dressing For Reduction Of InfectionUProduct Code
- QXWCryoablation Device For Local Treatment Of Low-Risk Breast Cancer2Product Code
- Submissions with No Product CodeMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
MariGen Wound Extra
- Page Type
- Cleared 510(K)
- 510(k) Number
- K190528
- 510(k) Type
- Traditional
- Applicant
- Kerecis Limited
- Country
- Iceland
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/10/2019
- Days to Decision
- 128 days
- Submission Type
- Summary