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
- 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
- K240713TRAUMAGEL®UCleared 510(K)
- K240097Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5)UCleared 510(K)
- K232216Hemoblock_S (Prescription); Hemoblock_S (OTC)UCleared 510(K)
- K240454RESPONDER® Polysaccharide HemostatUCleared 510(K)
- K220525RESPONDER Polysaccharide HemostatUCleared 510(K)
- K230589Celox Rapid X-Ray GauzeUCleared 510(K)
- K211570Zeolite Hemostatic GauzeUCleared 510(K)
- K202830Axiostat PatchUCleared 510(K)
- K192671Hemostatic Xerogel SpongeUCleared 510(K)
- K190012OMNI-STAT Vascular (Rapid); CELOX Vascular RapidUCleared 510(K)
- K183622NasalCEASE and BleedCEASEUCleared 510(K)
- K192667gel-e Flex+ gel OTCUCleared 510(K)
- K182811gel-e Flex+UCleared 510(K)
- K181641QuikClot RadialUCleared 510(K)
- K180893IHM Technology BandageUCleared 510(K)
- K180152gel-e FlexUCleared 510(K)
- K172155StatGuard Hemostatic Patch, StatGuard Hemostatic DressingUCleared 510(K)
- K172324Axiostat Chitosan Hemostatic DressingUCleared 510(K)
- K161274Bondiloxs Topical Hemostatic GranulesUCleared 510(K)
- K161013InnoSEAL Hemostatic PadUCleared 510(K)
- K160679WoundClot9UCleared 510(K)
- K160578Nustat XRUCleared 510(K)
- K160130BloodSTOP iX Battle MatrixUCleared 510(K)
- K153582Prometheus ChitoGauze XR PROUCleared 510(K)
- K150916HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO, ChitoFlex PROUCleared 510(K)
- K150963AnsCare ChitoClot PadUCleared 510(K)
- K151204HEMO-BandageUCleared 510(K)
- K143466Hemogrip PatchUCleared 510(K)
- K143462AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use)UCleared 510(K)
- K142363NUSTAT, NUSTAT XRUCleared 510(K)
- K140573WOUNDCLOT HEMOSTATIC GAUZEUCleared 510(K)
- K140313STOPSBLEEDING TOPICAL HEMOSTAT POWDER AND FOAMUCleared 510(K)
- K140757D2 HEMOSTANTIC DRESSINGUCleared 510(K)
- K132333BONDILOXS TOPICAL HEMOSTATIC DRESSINGUCleared 510(K)
- K133121CHITO-SAM 100,4IN X4IN,CHITO-SAM, 3IN X6FT, CHITO-SAM 100,3IN X10FT, CHITO-SAM ACTIVE, 4INX4IN,CHITO-SAM ACTIVE, 3INX6FTUCleared 510(K)
- K130324STATSEAL DISCUCleared 510(K)
- K123387QUIKCLOT HEMOSTATIC DRESSINGUCleared 510(K)
- K120782INTERVENTIONAL HEMOSTATIC BANDAGEUCleared 510(K)
- K122886NEXSTAT PLUS AND NEXFOAM PLUS TOPICAL HEMOSTAT DRESSINGUCleared 510(K)
- K121485GUARDIVA ANTIMICROBIAL HAEMSTATIC IV DRESSINGUCleared 510(K)
- K112864SOFTSEAL-CUCleared 510(K)
- K113560CELOX GAUZE PROUCleared 510(K)
- K120958POSISEP AND POSISEP X HEMOSTAT DRESSINGSUCleared 510(K)
- K112800SUNTOUCH TOPICAL HEMOSTATIC DRESSINGUCleared 510(K)
- K112215HEMCON HEMOSTATIC GELUCleared 510(K)
- K101257ADVANCED TRAUMA DRESSING (ATD)UCleared 510(K)
- K112961CLO-SURPLUS P.A.D.UCleared 510(K)
- K102944CORELEADER HEMO-PAD MODEL CPII 02030UCleared 510(K)
- K103641GUARDACAREUCleared 510(K)
- K111163CHITOGAUZE FUSIONUCleared 510(K)
- K110386CELOX RAPID GAUZEUCleared 510(K)
- K103245CELSTATUCleared 510(K)
- K102742NASAL CEASEUCleared 510(K)
- K102965CELOX TRAUMA GAUZE AG, CELOX HEMOSTATIC ANTIBACTERIAL TRAUMA GAUZE, OMNI-STAT TRAUMA GAUZE AG, OMNI-STAT HEMOSTATIC ANTIUCleared 510(K)
- K102459NEXSTAT (TM) TOPICAL HEMOSTAT POWDER; NEXFOAM (R) TOPICAL SPONGEUCleared 510(K)
- K102546CHITOGAUZEUCleared 510(K)
- K101097CALGAESEAL MODEL: CASUCleared 510(K)
- K093729GUARDIVA ANTIMICROBIAL HAEMOSTATIC IV DRESSING, 1 IN/ 4MM, STERILE, GUARD IVA ANTIMICROBIAL HAEMOSTATIC IV DRESSING, 1 IUCleared 510(K)
- K093593CELOX PRO, CELOX PRO OTC, CELOX HEMOSTATIC GRANULES, CELOX PRO HEMOSTATIC GRANULES, OMNI STAT PROUCleared 510(K)
- K093519MEDTRADE PRODUCTS CELOX VASCULAR TOPICAL HEMOSTATIC GRANULES ON SHEETUCleared 510(K)
- K091795MEDTRADE PRODUCTS CELOX TRAUMA GAUZEUCleared 510(K)
- K090780MEDTRADE PRODUCTS CELOX TOPICAL HEMOSTATIC PASTEUCleared 510(K)
- K092552CLO-SURPLUS P.A.D.UCleared 510(K)
- K092357CHITOGAUZE,2 IN X 2 IN,8 PLY, 4 IN X 4 IN 8 PLY, 4 IN X 8 IN, 8PLY, 1 IN X 4 IN, 8PLY, CHITOGAUZE, PACKAGING STRIP, 1/2UCleared 510(K)
- K091194ALGISEAL PADUCleared 510(K)
- K090620QUIKCLOT INTEVENTIONAL, MODEL P/N 182UCleared 510(K)
- K090026CHITOGAUZE, MODELS 130, 131, 263, 264, 265, 266UCleared 510(K)
- K090100SOFTSEAL-STFUCleared 510(K)
- K080210PRO QR ADVANCED FORMULA POWDERUCleared 510(K)
- K080532BENACEL, MODELS C-001, C-002 AND C-005UCleared 510(K)
- K082601UltraClot, UltraClot OTCUCleared 510(K)
- K072486MODIFICATION TO HEMCON BANDAGE AND HEMCON BANDAGE OTCUCleared 510(K)
- K080097MEDTRADE PRODUCTS CELOX HEMOSTATIC GRANULES ON SHEETUCleared 510(K)
- K081183WOUNDSTATUCleared 510(K)
- K080818HEMCON BANDAGE, HEMCON BANDAGE OTC, HEMCON CHITOFLEX-SURGICAL DRESSINGUCleared 510(K)
- K080648TRAUMASTAT RAPID HEMOSTATIC WOUND DRESSING BANDAGEUCleared 510(K)
- K072328MEDTRADE PRODUCTS CELOX SOLBAG, ANTI - COAGULANTUCleared 510(K)
- K072890STASILON FRUCleared 510(K)
- K072681BLOODSTOP HEMOSTATIC GAUZE; IX HEMOSTATIC GAUZEUCleared 510(K)
- K072900EXCELARREST FOAMUCleared 510(K)
- K070520PRO QR (QUICK RELIEF) POWDER (FOR MINOR EXTERNAL BLEEDING FROM WOUNDS & PROCEDURES)UCleared 510(K)
- K072474QUIKCLOT EXUCleared 510(K)
- K071578BLOODSTOP AND BLOODSTOP IX HEMOSTATIC GAUZE, MODELS BS-10,BS-11,BS-12,B-13, BS-IX27, BS-IX-14, BSIX-15, BSIX-17UCleared 510(K)
- K071936WOUNDSTAT, MODEL TC1001UCleared 510(K)
- K063190SILVERSEAL WOUND PACKING STRIPS WITH X-STATICUCleared 510(K)
- K071519HEMCON CHITOFLEX-SURGICAL DRESSINGUCleared 510(K)
- K070175AQUANOVA SUPER-ABSORBENT GELLING DRESSING, OTCUCleared 510(K)
- K070211TRAUMARREST AND BLEEDARREST HEMOSTATIC PARTICLES AND FOAMUCleared 510(K)
- K070010QUIKCLOT SPORT AND QUIKCLOT SPORT SILVERUCleared 510(K)
- K061722BLOXX RAPID CLOTTING AGENTUCleared 510(K)
- K061767QUIKCLOT 1ST RESPONSE & QUIKCLOT ACS+UCleared 510(K)
- K061079MEDTRADE PRODUCTS CELOX TOPICAL HEMOSTATIC GRANULES, MEDTRADE PRODUCTS CELOX 762 HEMOSTATIC GRANULESUCleared 510(K)
- K060409HEMOHALT HEMOSTASIS PADUCleared 510(K)
- K051955QUICKCLOT ACS - ACCELERATED CLOTTING SPONGEUCleared 510(K)
- K040283BIOPADUCleared 510(K)
- K043050HEMCON BANDAGE AND HEMCON BANDAGE OTCUCleared 510(K)
- K050769QUIKCLOT BRAND HEMOSTATIC AGENT - ADVANCED BEADED FORMULATION - 100G - 1.9MM - 2.4MM., MODEL 100172UCleared 510(K)
- K040208NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BANDUCleared 510(K)
- K033291TOPSEAL HEMOSTATIC DRESSING, MODEL 11150UCleared 510(K)
- K032986CLO-SURPLUSP.A.D.UCleared 510(K)
- K033666HEMADERMUCleared 510(K)
- K030946HEMCON BANDAGE OTC; HEMCON CATH/AIDUCleared 510(K)
- K030334T-SCIENTIFIC T-PADUCleared 510(K)
- K023298HEMCON BANDAGEUCleared 510(K)
- K021062CHITO-SEALUCleared 510(K)
- K021678HEMADERM COTAINING HEMADEX CLOTTING BEADSUCleared 510(K)
- K021581HEMOSORBUCleared 510(K)
- K013390QUICKCLOTUCleared 510(K)
- K010933SEAL-ON TOPICAL HEMPSTATIC POWDER SPRAYUCleared 510(K)
- K9826383M TEGAGEN HI ALGINATE DRESSING & 3 M TEGAGEN HG ALGINATE DRESSING, MODEL #'S 90110,90112,90114,90120, 90210,90212,90214UCleared 510(K)
- K965034SORBASTACEUCleared 510(K)
- 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
gel-e Flex+
- Page Type
- Cleared 510(K)
- 510(k) Number
- K182811
- 510(k) Type
- Traditional
- Applicant
- gel-e, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/29/2019
- Days to Decision
- 330 days
- Submission Type
- Summary