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
- 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
- K171879HylaGuard Moisturizing CreamUCleared 510(K)
- K083024HYLATOPIC EMOLLIENT FOAMUCleared 510(K)
- K041342IMPRUV A.I. CREAM WOUND AND SKIN EMULSIONUCleared 510(K)
- K041268SILVERSITE OR CALGITROLUCleared 510(K)
- K040019SILVERSEALUCleared 510(K)
- K040517TENDERWET ACTIVEUCleared 510(K)
- K022587MEDTRADE PRODUCT'S ANTISEPTIC BARRIER HYDROGEL DRESSINGSUCleared 510(K)
- K024367SINCLAIR WOUND AND SKIN EMULSIONUCleared 510(K)
- K024054XYLOS XCELL ANTIMICROBIAL DRESSINGUCleared 510(K)
- K022584CARDIOTECH ANTIBOTIC HYDROGEL WOUND DRESSINGUCleared 510(K)
- K022995COLLATEK HYDROGELUCleared 510(K)
- K020540REGENECARE WOUND GELUCleared 510(K)
- K013525CONTREET-H ANTIMICROBIAL HYDROCOLLOID DRESSING, MODELS 9610 (4 X 4 (10 CM X 10CM), 9613 (6X6 (15CM X 15CM)UCleared 510(K)
- K020325L.A.M. IPM WOUND GELUCleared 510(K)
- K011994ACRYDERM SILVER ANTTIMICROBIAL WOUND GEL MODEL# A-002101UCleared 510(K)
- K010583AMBU GEL, HYDROGEL BURN DRESSINGUCleared 510(K)
- K002666DIAMOND ALOE VERA, STERILEUCleared 510(K)
- K003396BURN JEL PLUSUCleared 510(K)
- K002077GLUCANPRO CREAMUCleared 510(K)
- K002078BETA GLUCAN GEL (MACROPRO GEL)UCleared 510(K)
- K002129FERRIS POLYMEM STERILE WOUND DRESSING WITH COLLAGENUCleared 510(K)
- K000519GLUCANPROUCleared 510(K)
- K000518MACROPRO GELUCleared 510(K)
- K991755MEDLINE TENDER WET WOUND DRESSINGUCleared 510(K)
- K992074MPM REGENECARE WOUND GELUCleared 510(K)
- K993119STERILE HYDROGELUCleared 510(K)
- K990179BURNFREE 1/8 OZ. STERILE PAIN RELIEVING GEL, MODEL SDUCleared 510(K)
- K990180BURNFREE (4X4, 8X8, 16X24) STERILE BURN & WOUND DRESSINGUCleared 510(K)
- K990178BURNFREE PAIN RELIEVING GEL, MODEL 4BUCleared 510(K)
- K990440GENTELL HYDROGEL SPRAY GEL, APPLIGARD SQUEEZEUCleared 510(K)
- K991202MODIFICATION TO WOUN'DRESUCleared 510(K)
- K990368DUODERM HYDROACTIVE GEL WOUND DRESSINGUCleared 510(K)
- K984370HYPERGEL 20% HYPERTONIC SALINE GELUCleared 510(K)
- K984368NORMLGEL 0.9% ISOTONIC SALINE GELUCleared 510(K)
- K984267MODIFICATION OF BIONECT HYDROGEL FOAMUCleared 510(K)
- K984262MODIFICATION OF BIONECT HYDROGEL GAUZE PADSUCleared 510(K)
- K984264MODIFICATION OF BIONECT CLEAR HYDROGELUCleared 510(K)
- K984266MODIFICATION OF BIONECT HYDROGEL SPRAYUCleared 510(K)
- K984413BIONECT HYDROGELUCleared 510(K)
- K984082BURN-AID HYDROGEL, BURN-AID BURN DRESSING, BURN-AID BURN BLANKETUCleared 510(K)
- K983362NU-GEL * WOUND DRESSINGUCleared 510(K)
- K982804SPYROGEL HYDROGEL WOUND AND BURN DRESSINGUCleared 510(K)
- K983042SWEEN WOUN'DRESUCleared 510(K)
- K982825BRENNEN MEDICAL BETA GLUCAN GELUCleared 510(K)
- K982577NEUFINISH RESURFACING CREAMUCleared 510(K)
- K982306POLYTUBEUCleared 510(K)
- K973721BIONECT HYDROGEL GAUZE PADSUCleared 510(K)
- K973725BIONECT CLEAR HYDROGELUCleared 510(K)
- K973724BIONECT HYDROGEL SPRAYUCleared 510(K)
- K973722BIONECT HYDROGEL FOAMUCleared 510(K)
- K980962BRENNEN MEDICAL BETA GLUCAN CREAM, MACROPROUCleared 510(K)
- K980132PHYTACARE ALGINATE HYDROGEL WOUND DRESSINGUCleared 510(K)
- K981150SOLOSITE GEL CONFORMABLE DRESSINGUCleared 510(K)
- K974251X-CELL WOUND DRESSINGUCleared 510(K)
- K980861DUMEX PAK-ITS COTTON GAUZE PACKING IMPREGNATED WITH HYDROGELUCleared 510(K)
- K980097FLEXIGEL-G HYDROGEL WOUND DRESSINGUCleared 510(K)
- K973806DUODERM HYDROACTIVE GELUCleared 510(K)
- K973693AQUA PATCHUCleared 510(K)
- K971918AMERIGEL OINTMENT SATURATED WOUND DRESSINGUCleared 510(K)
- K970153LAMIN-2 HYDRATING GELUCleared 510(K)
- K965143OSMOCYTE WOUND MANAGER SHEET DRESSINGUCleared 510(K)
- K970133AMERIGEL OINTMENTUCleared 510(K)
- K970453B. BRAUN MEDICAL INC. TRANSORBENT AND THINSITE BORDER DRESSINGUCleared 510(K)
- K970693ACRYDERM GEL WOUND DRESSINGUCleared 510(K)
- K965005IAMIN IMPREGNATED GAUZE DRESSINGUCleared 510(K)
- K963004BIONECT CREAMUCleared 510(K)
- K964468IAMIN WET DRESSING (COPPER-SALINE)UCleared 510(K)
- K964240BIAFINE WOUND DRESSING EMULSIONUCleared 510(K)
- K964620PANOGAUZE NON-WOVEN HYDROGEL DRESSINGUCleared 510(K)
- K962917MULTIDEX HYDROPHILIC WOUND DRESSING GELUCleared 510(K)
- K964241BRENNEN MEDICAL GLUCAN II WOUND DRESSINGUCleared 510(K)
- K962089DERMAMEND GELUCleared 510(K)
- K961930CHONDROPROTECUCleared 510(K)
- K962513DERMAPLEX HYDROGEL WOUND DRESSINGUCleared 510(K)
- K962218CARRASYN HYDROGEL WOUND DRESSING,CARRAGAUZE PADS,CARRAGAUZE STRIPS,CARRASORB M FDGUCleared 510(K)
- K962851ACRYNOODLES ABSORBENT WOUND DRESSINGUCleared 510(K)
- K962439DERMAPLEX HYDROGEL WOUND DRESSING (2X2,4X4,4X8,6X10)UCleared 510(K)
- K960686HYCOATUCleared 510(K)
- K961766WOUND HYDROGEL & STERILE WOUND HYDROGELUCleared 510(K)
- K961316WOUND HYDROGEL AND/OR STERILE WOUND HYDROGELUCleared 510(K)
- K961758CARASYN HYDROGEL WOUND PRODUCTSUCleared 510(K)
- K962160MPM HYDROGEL DRESSING (NON-STERILE)UCleared 510(K)
- K961085DEROYAL WOUND CARE MULTIDEX PLUS GEL WOUND DRESSINGUCleared 510(K)
- K961067BURN-AID HYDROGEL,BURN DRESSING,BURN BLANKETUCleared 510(K)
- K960428CARRASYN HYDROGEL WOUND DRESSING/FDG PADS/CARAGAUZE STRIPS/PADS (MODIFICATION)UCleared 510(K)
- K955400QUEGEL HYDROPHILIC WOUND DRESSINGUCleared 510(K)
- K953505BURNAID BURN FIRST AID DRESSINGUCleared 510(K)
- K953853IAMIN GEL WOUND DRESSINGUCleared 510(K)
- K955575TECNOL HYDROGEL WOUND DRESSINGUCleared 510(K)
- K952938AQUAFLO BTP HYDROGEL WOUND DRESSINGUCleared 510(K)
- K954741DERMAGRAN WENT DRESSING (DEXTROSE-SALINE)UCleared 510(K)
- K954664DERMAGRAN (ZINC SALINE) HYDROGEL WOUND DRESSINGUCleared 510(K)
- K954384WOUND HYDROGEL AND/OR STERILE WOUND HYDROGELUCleared 510(K)
- K953423CASRRASYN ORAL WOUND DRESSINGUCleared 510(K)
- K952775DEROYAL WOUND CARE MULTIDEX GEL WOUND DRESSINGUCleared 510(K)
- K953669PERSPECTIVES IMPREGNATED HYDROGEL WOUND DRESSINGUCleared 510(K)
- K953816DCURASOL GEL WOUND DRESSINGUCleared 510(K)
- K952945AQUAFLO HYDROGEL WOUND DRESSING & PACKERUCleared 510(K)
- K953450CURASOL GEL WOUND DRESSINGUCleared 510(K)
- K952419STERIGAUZE GEL DRESSINGUCleared 510(K)
- K952247BURNSHIELD TRAUMA DRESSINGUCleared 510(K)
- K952774MULTIDEX GELUCleared 510(K)
- K951862A GEL WOUND DRESSINGUCleared 510(K)
- K951861STERICARE WOUND CARE GELUCleared 510(K)
- K952276MPM HYDROGEL DRESSINGUCleared 510(K)
- K951166BIODERM MEDICAL HYDROGEL ISLAND DRESSINGUCleared 510(K)
- K950934MPM HYDROGEL DRESSINGUCleared 510(K)
- K945217HYDROGEL DRESSINGUCleared 510(K)
- K951417CARRASYN HYDROGEL WOUND DRESSING, FDG PADS, CARRAGAUZE PADS, STRIPSUCleared 510(K)
- K950412CURAGEL HYDROGEL WOUND DRESSINGUCleared 510(K)
- K945005PANOPLEX HYDROGEL WOUND DRESSINGUCleared 510(K)
- K945832BRADY MEDICAL PRODUCTS TRANSCORBENT AND THINSITE TOPICAL BORDER WOUND DRESSINGSUCleared 510(K)
- K946030DERMASSIST(TM) HYDROGEL SATURATED GAUZE DRESSINGUCleared 510(K)
- K946031DERMASSIST(TM) HYDROGEL SATURATEED NON WOVEN DRESSINGUCleared 510(K)
- K943910BIAFINEUCleared 510(K)
- K945835ARGIDENE(TM) GELUCleared 510(K)
- K945313SPARTA HYDROGEL WOUND DRESSINGUCleared 510(K)
- K944427CARRASYN FDGUCleared 510(K)
- K944333HYDRODERM GEL WOUND DRESSINGUCleared 510(K)
- K943728BURNFREE BURNSOOTHE HYDROGELUCleared 510(K)
- K943470BURNFREE BURNSOOTHE HYDROGEL BURN BLOTTSUCleared 510(K)
- K942419HYDRO-S WOUND GELUCleared 510(K)
- K943073CURAFIL WOUND GEL DRESSINGUCleared 510(K)
- K932291EUTRA GEL FOR WOUND DRESSINGUCleared 510(K)
- K942798MPM HYDROGELUCleared 510(K)
- K940409M-K HYDROGEL DRESSINGUCleared 510(K)
- K942748INTRASITEUCleared 510(K)
- K941339STERILE WOUND HYDROGEL DRESSINGUCleared 510(K)
- K940814HYDRO-M(TM) WOUND GELUCleared 510(K)
- K941019BRADY MEDICAL PRODUCTS TRANSORBENTS WOUND DRESSINGUCleared 510(K)
- K933741CARRASYN ORAL WOUND DRESSINGUCleared 510(K)
- K926353FLOWGEL(R) TOPICAL WOUND DRESSINGUCleared 510(K)
- K935096BIOLEX IMPREGNATED WOUND DRESSINGUCleared 510(K)
- K935848BRADY MEDICAL PRODUCTS TRANSORB WOUND DRESSINGUCleared 510(K)
- K935705ALLEVYN ISLAND WOUND DRESSINGUCleared 510(K)
- K934601NDM HYDROGAUZE WOUND DRESSINGUCleared 510(K)
- K932336NU-GEL ISLAND WOUND DRESSINGUCleared 510(K)
- K935203WOUND HYDROGEL AND/OR STERILE WOUND HYDROGELUCleared 510(K)
- K933495MPM GELPAD (HYDROGEL SATURATED STERILE GAUZE PADS)UCleared 510(K)
- K933817ROYL-DERM WOUND HYDROGEL STERILE UNIT DOSEUCleared 510(K)
- K932973ROYL-DERM WOUND HYDROGEL DRESSINGUCleared 510(K)
- K932101DUODERM IMPROVED CGF CONTROL GEL FORMULA DRESSINGUCleared 510(K)
- K931618DUODERM HYDROCOLLOID GELUCleared 510(K)
- K934267DAMOR CREAM SATURATED DRESSINGUCleared 510(K)
- K933328DAMOR CREMEUCleared 510(K)
- K932263SOLOSITE DERMAL WOUND GELUCleared 510(K)
- K926508INTRASITE GELUCleared 510(K)
- K930560MPM HYDROGEL SATURATED DRESSINGUCleared 510(K)
- K926389SWEEN WOUND CARE-COLLAGEN WOUND DRESSINGUCleared 510(K)
- K926202CLEARSITE STERILE WOUND DRESSING, NDM WOUND DRESSIUCleared 510(K)
- K920554KOLD WRAP STERILE BURN DRESSINGUCleared 510(K)
- K922666TRANSORB(TM) ULCER & WOUND DRESSINGUCleared 510(K)
- K922815ROYL-DERM WOUND HYDROGELUCleared 510(K)
- K921810CURASOL(TM) WOUND DRESSINGUCleared 510(K)
- K913344DERMAGRAN WET DRESSING (ZINC-SALINE)UCleared 510(K)
- K914746DERMAGRAN WET DRESSINGUCleared 510(K)
- K912565MICRO-COLL COLLAGEN WOUND SPRAYUCleared 510(K)
- K915357PROMEON HYDROGEL DRESSING #45 STERILE W/O MESHUCleared 510(K)
- K915359PROMEON HYDROGEL DRESSING #45 STERILE W/ MESHUCleared 510(K)
- K920642MICRO-COLL COLLAGEN DERMAL WOUND SPRAYUCleared 510(K)
- K920677CLEARSITE HYDROGEL WOUND DRESSING MODIFICATIONUCleared 510(K)
- K915182DEROYAL HYDROGEL DRESSINGUCleared 510(K)
- K920050BIOLEX WOUND GEL,UCleared 510(K)
- K915001CARRINGTON WOUND DRESSING 4X4(TM)UCleared 510(K)
- K915002STERILE GAUZE PK STRIPS SAT W/CARR GEL WOUND DRESSUCleared 510(K)
- K914207CLEARSITE(R) STERILE WOUND CARE DRESSINGUCleared 510(K)
- K9115502ND SKIN MOIST BURN PADS WITH ALOEUCleared 510(K)
- K912667DUODERM HYDROACTIVE DRESSING AND CGF DRESSINGSUCleared 510(K)
- 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
BURNFREE BURNSOOTHE HYDROGEL
- Page Type
- Cleared 510(K)
- 510(k) Number
- K943728
- 510(k) Type
- Traditional
- Applicant
- LEVTRADE INTL. (PTY) LTD.
- Country
- United States
- FDA Decision
- Substantially Equivalent for Some Indications
- Decision Date
- 9/27/1994
- Days to Decision
- 70 days
- Submission Type
- Summary