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
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Neurological Diagnostic DevicesCFR Sub-Part
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- GXOStrip, Craniosynostosis, Preformed2Product Code
- GXPMethyl Methacrylate For Cranioplasty2Product Code
- GXQDura Substitute2Product Code
- GXRCover, Burr Hole2Product Code
- GXTMonitor, Lesion Temperature2Product Code
- GWOPlate, Cranioplasty, Preformed, Alterable2Product Code
- GXCDevice, Electroconvulsive Therapy3Product Code
- GXNPlate, Cranioplasty, Preformed, Non-Alterable2Product Code
- GYZStimulator, Intracerebral/Subcortical, Implanted3Product Code
- GZAImplanted Cerebellar Stimulator3Product Code
- GZBStimulator, Spinal-Cord, Implanted (Pain Relief)2Product Code
- GZFStimulator, Peripheral Nerve, Implanted (Pain Relief)2Product Code
- GZIStimulator, Neuromuscular, External Functional2Product Code
- GZJStimulator, Nerve, Transcutaneous, For Pain Relief2Product Code
- HAXTong, Skull For Traction2Product Code
- HBPClip, Implanted Malleable2Product Code
- HBWFastener, Plate, Cranioplasty2Product Code
- HBZCatheter, Intravascular Occluding3Product Code
- HCBDevice, Aversive Conditioning2Product Code
- HCCDevice, Biofeedback2Product Code
- HCEClamp, Carotid Artery2Product Code
- HCGDevice, Neurovascular Embolization2Product Code
- K232955Numen Coil Embolization System; NumenFR Detachment System2Cleared 510(K)
- K233420Axium Detachable Coil; Axium Prime Detachable Coil2Cleared 510(K)
- K230284Penumbra LP Coil System2Cleared 510(K)
- K222533Target Tetra Detachable Coils2Cleared 510(K)
- K223386Optima Coil System2Cleared 510(K)
- K220040CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini, and Freeform XtraSoft Detachable Coil Systems2Cleared 510(K)
- K212455InZone Detachment System2Cleared 510(K)
- K203625Numen Coil Embolization System; NumenFR Detachment System2Cleared 510(K)
- K203432Axium Detachable Coil; Axium Prime Detachable Coil2Cleared 510(K)
- K211344MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini Microcoil Delivery Systems2Cleared 510(K)
- K210638i-ED COIL System2Cleared 510(K)
- K192068i-ED COIL2Cleared 510(K)
- K200030Optima Coil System2Cleared 510(K)
- K192955Penumbra LP Coil System2Cleared 510(K)
- K180653Spartan eCoil System2Cleared 510(K)
- K173711Wallaby Avenir Coil System2Cleared 510(K)
- K173614Penumbra Coil 400, Ruby Coil System, POD System2Cleared 510(K)
- K172390Optima Coil System2Cleared 510(K)
- K171862GALAXY G3 Mini Microcoil Delivery System2Cleared 510(K)
- K170852POD Packing Coil2Cleared 510(K)
- K171747MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch Resistant Microcoil Delivery System, DELTAFILL 18 Stretch Resistant Microcoil Delivery System, DELTAXSFT 10 Stretch Resistant Microcoil Delivery System, GALAXY G3 FILL and GALAXY G3 XSFT Stretch Resistant Microcoil Delivery System2Cleared 510(K)
- K162999V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System2Cleared 510(K)
- K162704Axium Prime Detachable Coil System2Cleared 510(K)
- K161452MicroPlex Coil System (MCS) - HyperSoft 3D2Cleared 510(K)
- K161367HydroCoil Embolic System (HES)2Cleared 510(K)
- K161429Target Detachable Coils2Cleared 510(K)
- K153658Target Detachable Coils2Cleared 510(K)
- K160832Penumbra Smart Coil2Cleared 510(K)
- K160096InZone Detachment System2Cleared 510(K)
- K153594MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)2Cleared 510(K)
- K151447Axium Detachable Coil System2Cleared 510(K)
- K151760Barricade Embolization Coil System2Cleared 510(K)
- K151572Penumbra Smart Coil2Cleared 510(K)
- K150319MICRUSFRAME 10/18, DELTAFILL 18, DELTAXSFT 10, GALAXY G3 FILL/XSFT STRETCH RESISTANT MICROCOIL DELIVERY SYSTEMS2Cleared 510(K)
- K143218Penumbra Smart Coil2Cleared 510(K)
- K142429CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT GALAXY G2 Microcoil Delivery System, EnPower Control Cable, Connector Cable2Cleared 510(K)
- K142513Barricade Embolization Coil System2Cleared 510(K)
- K141134POD SYSTEM2Cleared 510(K)
- K140104BARRICADE EMBOLIZATION COIL SYSTEM2Cleared 510(K)
- K133310AXIUM DETACHABLE COIL SYSTEM2Cleared 510(K)
- K132952MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES)2Cleared 510(K)
- K132482BARRICADE EMBOLIZATION COIL SYSTEM2Cleared 510(K)
- K131948MICROPLEX COIL SYSTEM (MCS)2Cleared 510(K)
- K132317MICROPLEX COIL SYSTEM (MCS), VFC2Cleared 510(K)
- K131475BARRICADE EMBOLIZATION COIL SYSTEM2Cleared 510(K)
- K123338BARRICADE EMBOLIZATION COIL SYSTEM2Cleared 510(K)
- K123560VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS), AND TRUFILL DCS ORBIT DETACHABLE COIL SYSEM2Cleared 510(K)
- K123377TARGET DETACHABLE COIL2Cleared 510(K)
- K120908HYDROCOIL EMBOLIC SYSTEM (HES)2Cleared 510(K)
- K120850TARGET DETACHABLE COIL2Cleared 510(K)
- K120686ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM2Cleared 510(K)
- K120330PENUMBRA COIL SYSTEM/PENUMBRA COIL 4002Cleared 510(K)
- K113822QUADRASPHERE 30 TO 602Cleared 510(K)
- K120274DELTAMAXX 18 MICROCOIL SYSTEM2Cleared 510(K)
- K113457HYDROCOIL EMBOLIC SYSTEM (HES)2Cleared 510(K)
- K113412TARGET DETACHABLE COIL2Cleared 510(K)
- K112181HYDROCOIL(R) EMBOLIC SYSTEM (HES)2Cleared 510(K)
- K112226HYDROCOIL EMBOLIC SYSTEM (HES)2Cleared 510(K)
- K111451MICROPLEX COIL SYSTEM-VECTOR MODEL 030606XXX-V, 030610XXX-V, 30615XXX-V, 061020XXX-V, 061030XXX-V, 101530XXX-V, 101540XX2Cleared 510(K)
- K112385TRAGET DETACHABLE COIL2Cleared 510(K)
- K103758MICROPLEX COIL SYSTEM- COSMOS 10, HYDROCOIL SYSTEM- HYDROFRAME 102Cleared 510(K)
- K103355GDC 360 DETEACHABLE COIL2Cleared 510(K)
- K103305PENUMBRA EMBOLIZATION COIL SYSTEM2Cleared 510(K)
- K103008INZONE DETACHMENT SYSTEM2Cleared 510(K)
- K102672TARGET DETACHABLE COIL2Cleared 510(K)
- K093973TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM2Cleared 510(K)
- K100454HYDROCOIL EMBOLIC SYSTEM-HYDROFRAME MODEL 100931HFM-V, 101243HFM-V, 180827HFM-V, 181139HFM-V, 181445HFM-V, 181850HFM-V2Cleared 510(K)
- K094018LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES2Cleared 510(K)
- K093142TARGET DETACHABLE COILS AND INZONE DETACHMENT SYSTEM2Cleared 510(K)
- K093919MICROPLEX COIL SYSTEM-COSMOS MODEL 100933CSSR-V, 101036CSSR-V, 101141CSSR-V, 101245CSSR-V2Cleared 510(K)
- K093358MICROPLEX COIL SYSTEM-COSMOS, MODELS 81451CS-V, 181555CS-V, 16=81652CS-V2Cleared 510(K)
- K092666INZONE DETACHMENT SYSTEM, MODEL M00345100940, IZDS CONNECTING CABLE, MODEL M003451002502Cleared 510(K)
- K091641HYDROCOIL EMBOLIC SYSTEM (HYDROSOFT) AND MICROPLEX COIL SYSTEM (HYPERSOFT)2Cleared 510(K)
- K090891MICROPLEX COIL SYSTEM-COSMOS2Cleared 510(K)
- K090357HYDROFRAME (HES)2Cleared 510(K)
- K090168AZUR DETACTABLE 18, MODELS 45-480305, 45-480310, 45-480405, 44-4804152Cleared 510(K)
- K090001V-GRIP PLUS DETACHMENT CONTROLLER, MODEL VG5032Cleared 510(K)
- K083646MICRUS MICROCOLI SYSTEM, DELTAPLUSH, MODELS CPL, DPL2Cleared 510(K)
- K082739MICRUS MICROCOIL DELIVERY SYSTEM2Cleared 510(K)
- K082461BARE PLATINUM FRAMING COIL, MODEL(S) 100408BPFC-V,100412BPFC-V,100515BPFC-V100518BPFC-V,100522BPFC-V,100618BPFC-V100622B2Cleared 510(K)
- K082324TRUFILL DCS SYRINGE2Cleared 510(K)
- K080666HYDROSOFT AND HYDROSOFT PLUS EMBOLIZATION COIL SYSTEMS2Cleared 510(K)
- K080379MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 STRETCH RESISTANT2Cleared 510(K)
- K080437MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 CERECYTE, MODEL CDF2Cleared 510(K)
- K080967TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE OR TRUFILL DCS SYRINGE II, ALSO KNOWN AS THE TRUFILL DCS ORBIT2Cleared 510(K)
- K073442MICRUS MICROCOIL SYSTEMS2Cleared 510(K)
- K073419PVA PLUS VIAL PVA FOAM EMBOLIZATION PARTICLES, PVA PLUS CONVENIENCE KIT PVA EMBOLIZATION PARTICLES2Cleared 510(K)
- K072173MICRUS MICROCOIL SYSTEM CASHMERE-CERECYTE, MODEL CRC; CASHMERE-SR, MODEL SRC2Cleared 510(K)
- K071962VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS AND TRUPUSH COIL PUSHER)2Cleared 510(K)
- K071634MODIFICATION TO:CONTOUR SE MICROSPHERES2Cleared 510(K)
- K070656HYDROCOIL EMBOLIC SYSTEM (HES)2Cleared 510(K)
- K071246MICRUS MICROCOIL DELIVERY SYSTEM, MODELS SPH, HEL, CHE, PC4, HSR, FSR, CSP, CFS, SRC, PP4, STR2Cleared 510(K)
- K060747FX DETACHABLE COIL SYSTEM2Cleared 510(K)
- K070707MICRUS MICROCOIL SYSTEM2Cleared 510(K)
- K063653MICRUS MICROCOIL SYSTEM, CASHMERE MODEL SRC2Cleared 510(K)
- K052509M-BOLUS EMBOLIC MICROSPHERES2Cleared 510(K)
- K063254THE TRUFILL DCS DETACHABLE COIL SYSTEM; THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM2Cleared 510(K)
- K062036MICRUS MICROCOIL SYSTEM PRESIDIO-18, MODEL PC42Cleared 510(K)
- K060625NEXUS DETACHABLE COIL SYSTEM, MORPHEUS 3D CSR2Cleared 510(K)
- K053548MODIFIED PVA-PLUS FOAM EMBOLIZATION PARTICLES AND MAXISTAT AND MICROSTAT PVA FOAM EMBOLIZATION PARTICLES2Cleared 510(K)
- K053197TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM LINE EXTENSION2Cleared 510(K)
- K053160MICRUS MODIFIED MICROCOIL 18-SYSTEM, CERECYTE, MODEL CSP & CHE2Cleared 510(K)
- K051560NEXUS DETACHABLE COIL, MULTI-DIAMETER CSR AND HELIX SUPER SOFT CSR2Cleared 510(K)
- K050954MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES)2Cleared 510(K)
- K051425NEXUS DETACHABLE COIL SYSTEM, HELIX SUPER SOFT CSR2Cleared 510(K)
- K042297ULTRA IVALON AND ULTRA DRIVALON PVA EMBOLIZATION PARTICLES2Cleared 510(K)
- K050543NEXUS DETACHABLE COIL SYSTEM2Cleared 510(K)
- K050700MATRIX STRETCH RESISTANT (SR) COILS2Cleared 510(K)
- K042231GELSPHERES MICROSPHERES AND BEAD BLOCK COMPRESSIBLE MICROSPHERES2Cleared 510(K)
- K042539GDC-10 360 DEGREE COIL SR; GDC-10 360 DEGREE SOFT COIL SR; GDC-18 360 DEGREE COIL2Cleared 510(K)
- K041649SAPPHIRE NXT DETACHABLE COIL SYSTEM2Cleared 510(K)
- K041551MODIFICATION TO: HYDROCOIL EMBOLIC SYSTEM (HES)2Cleared 510(K)
- K040694MODIFICATION TO SAPPHIRE DETACHABLE COIL SYSTEM (TETRIS 3-D)2Cleared 510(K)
- K032619MICROSTAT PVA FOAM EMBOLIZATION PARTICLES2Cleared 510(K)
- K033813MICRUS MODIFIED MICROCOIL SYSTEM, CERECYTE2Cleared 510(K)
- K033761GELSPHERES / BEADBLOCK COMPRESSIBLE MICROSPHERES2Cleared 510(K)
- K033372SAPPHIRE DETACHABLE FIBERED COIL SYSTEM, HELIX FIBERED, CYCLONE, MULTIPLE MODELS2Cleared 510(K)
- K033836HYDROCOIL EMBOLIC SYSTEM (HES)2Cleared 510(K)
- K032872MICRUS MICROCOIL SYSTEM2Cleared 510(K)
- K032590MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES)2Cleared 510(K)
- K032497SAPPHIRE VDS TENSION SAFE DETACHABLE COIL, E-3-12/3-T10-VT2Cleared 510(K)
- K032707CONTOUR SE MICROSPHERES (SYRINGE)2Cleared 510(K)
- K032553TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM2Cleared 510(K)
- K032542MODIFICATION TO CONTOUR SE MICROSPHERES2Cleared 510(K)
- K031852SAPPHIRE DETACHABLE FIBER COILS2Cleared 510(K)
- K031578MICRUS MICROCOIL SYSTEMS, MODELS HEL, SPH, STR, FSR AND HSR2Cleared 510(K)
- K031049GUGLIELMI DETACHABLE COIL (GDC)2Cleared 510(K)
- K030392SAPPHIRE DETACHABLE COIL SYSTEM2Cleared 510(K)
- K030963TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM2Cleared 510(K)
- K031168MATRIX STRETCH RESISTANT DETACHABLE COIL2Cleared 510(K)
- K030475GDC STRETCH RESISTANT DETACHABLE COIL2Cleared 510(K)
- K023089GELSPHERES EMBOLIC AGENT2Cleared 510(K)
- K022420MICRUS STRETCH-RESISTANT MICROCOIL SYSTEM, MSR012Cleared 510(K)
- K022735MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES) WITH THE HYDROLINK SYRINGE KIT2Cleared 510(K)
- K022427CONTOUR SE MICROSPHERES2Cleared 510(K)
- K020434MICROPLEX COIL SYSTEM (MCS)2Cleared 510(K)
- K021914MICROPLEX COIL SYSTEMS (MCS)2Cleared 510(K)
- K021494GDC POWER SUPPLY, MODEL GDC POWER SUPPLY: 451007-42Cleared 510(K)
- K020033MAXISTAT PVA FOAM EMBOLIZATION PARTICLES2Cleared 510(K)
- K014041TRUFILL DCS DETACHABLE COIL AND FRUFILL DCS SYRINGE, ALSO KNOWN AS THE TRUFILL DCS DETACHABLE COIL SYSTEM2Cleared 510(K)
- K012985MATRIX DETACHABLE COILS2Cleared 510(K)
- K012145MICROPLEX COIL SYSTEM2Cleared 510(K)
- K010026EMBOGOLD MICROSPHERE2Cleared 510(K)
- K001678PVA FOAM EMBOLIZATION PARTICLES2Cleared 510(K)
- K002056MICRUS MICROCOIL DELIVERY SYSTEM, MDS032Cleared 510(K)
- K000651DETACH 18 AND DETACH 11, NEUROLOGICAL EMBOLIZATION COIL SYSTEM2Cleared 510(K)
- K002181GDC ULTRASOFT COIL2Cleared 510(K)
- K001083GUGLIELMI DETACHABLE COIL AND POWER SUPPLY, MODELS POWER SUPPLY : 451006-4; CABLES: 451102-42Cleared 510(K)
- K991549EMBOSPHERE MICROSPHERES2Cleared 510(K)
- K993418FIBERED GDC-18 VORTX SHAPE GUGLIELMI DETACHABLE COIL2Cleared 510(K)
- K993415GDC-10 STRETCH RESISTANT GUGLIELMI DETACHABLE COIL, GDC-10 2-DIAMETER STRETCH RESISTANT GUGLIELMI DETACHABLE COIL, GDC-12Cleared 510(K)
- K993417GDC-10 GUGLIELMI DETACHABLE COIL (GDC) (3D SHAPE GDC), GDC-18 GUGLIELMI DETACHABLE COIL (GDC) (3D SHAPE GDC)2Cleared 510(K)
- K991139GUGLIELMI DETACHABLE (GDC)2Cleared 510(K)
- K983483VASCULAR OCCLUSION SYSTEM2Cleared 510(K)
- K972881CES VASCULAR OCCLUSION SYSTEM2Cleared 510(K)
- K964021INTRAMED SIDE BRANCH OCCLUSION (SBO) SYSTEM (700095 AND 700099)2Cleared 510(K)
- K965174TRUFILL PVA PARTICLES2Cleared 510(K)
- K964367CES VASCULAR OCCLUSION SYSTEM2Cleared 510(K)
- K963307GDC PATIENT RETURN ELECTTRODE MODEL 450212Cleared 510(K)
- K962503GUGLIELMI DETACHABLE COIL2Cleared 510(K)
- K961923BERENSTEIN COIL2Cleared 510(K)
- K960705GUGLIELMI DETACHABLE COIL2Cleared 510(K)
- K951256DETACHABLE PLATINUM COIL (GUGLIELMI DETACHABLE COIL, GDC)2Cleared 510(K)
- K951314TRUEFILL PVA PARTICLES2Cleared 510(K)
- K944354CONTOUR EMBOLI2Cleared 510(K)
- K913556IVALON EMBOLIZATION PARTICLES2Cleared 510(K)
- K914866ITC CONTOUR EMBOLI, MODIFICATION2Cleared 510(K)
- K925876ITC BUNJI PLATINUM EMBOLIZATION COIL2Cleared 510(K)
- K925523ITC BUNJI PLATINUM EMBOLIZATION COIL2Cleared 510(K)
- K920324ITC BUNJI COIL (MODIFICATION)2Cleared 510(K)
- K913312HELIX SHAPED COILS WITH DACRON FIBERS, MODIFIED2Cleared 510(K)
- K911779HELIX SHAPED COILS WITH DACRON FIBERS, MODIFIED2Cleared 510(K)
- K900723ITC BUNJI COIL2Cleared 510(K)
- K901337HILAL EMBOLIZATION MICROCOIL(TM)2Cleared 510(K)
- K901721MODIFIED TARGET THERAPEUTICS COILS2Cleared 510(K)
- K891688COIL AND COIL DELIVERY SYSTEM2Cleared 510(K)
- K871047RADIOPAQUE SPHERICAL EMBOLI (RSE)2Cleared 510(K)
- HCHClip, Aneurysm2Product Code
- JXGShunt, Central Nervous System And Components2Product Code
- JXHMethyl Methacrylate For Aneurysmorrhaphy2Product Code
- JXICuff, Nerve2Product Code
- JXKCranial Electrotherapy Stimulator To Treat Depression3Product Code
- JXLBlock, Bite2Product Code
- LELDevice, Sleep Assessment2Product Code
- LHGElectrode, Spinal Epidural2Product Code
- LIHInterferential Current Therapy2Product Code
- MVAOrthosis, Cranial2Product Code
- MYUAccessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty2Product Code
- MZQBalloon, Detachable, For Neurovascular Occlusion2Product Code
- NFOStimulator, Transcutaneous Electrical, Aesthetic Purposes2Product Code
- NHIStimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief2Product Code
- NUFCatheter, Neurovasculature, Occluding Balloon3Product Code
- NUHStimulator, Nerve, Transcutaneous, Over-The-Counter2Product Code
- NYNStimulator, Electrical, Transcutaneous, For Arthritis2Product Code
- NYWStimulator, Nerve, Electrical, Transcutaneous, With Limited Output, For Pain Relief2Product Code
- NYXStimulator, Electrical, Transcutaneous, With Limited Output, For Aesthetic Purposes2Product Code
- OANOrthosis, Cranial, Laser Scan2Product Code
- OBPTranscranial Magnetic Stimulator2Product Code
- OBVEating Disorder Conditioning Tool2Product Code
- OCFStimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthritis Pain Relief2Product Code
- OKPTranscranial Magnetic Stimulator For The Treatment Of Migraine Headache2Product Code
- QMDTranscranial Magnetic Stimulation System For Smoking Cessation2Product Code
- OSGPiezo-Electric Stimulator For Relief Of Mosquito Bite Itch2Product Code
- PAVCatheter, Neuro-Vasculature, Occluding BalloonFProduct Code
- PBJCranial Distraction System2Product Code
- PCBExternal Cerebrospinal Fluid (Csf) Diversion2Product Code
- PCCStimulator, Nerve, Electrical, Transcutaneous, For Migraine2Product Code
- PJMFiller, Bone Void, Alterable Compound For Cranioplasty2Product Code
- PJNFiller, Bone Void, Non-Alterable Compound For Cranioplasty2Product Code
- PKRNon-Invasive Vagus Nerve Stimulator - Headache2Product Code
- PLUThermal System For Insomnia2Product Code
- POLNeurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment2Product Code
- PUUTemporary Coil Embolization Assist Device2Product Code
- PVLEndoscopic Shunt Placement Kit2Product Code
- PVOLumbar Drainage Catheter Kit2Product Code
- PWEComputerized Behavioral Therapy Device For Psychiatric Disorders2Product Code
- PZRPercutaneous Nerve Stimulator For Opioid Withdrawal2Product Code
- QAKNon-Invasive Vagus Nerve Stimulator For Migraine Headache2Product Code
- QARThermal Vestibular Stimulator For Headache2Product Code
- QBCExternal Upper Limb Tremor Stimulator2Product Code
- QCITranscranial Magnetic Stimulation System For Obsessive-Compulsive Disorder2Product Code
- QFDTens For Sinus Pain2Product Code
- QFFElectromechanical Arm For A Transcranial Magnetic Stimulation System2Product Code
- QGHElectroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder2Product Code
- QGLTranscutaneous Nerve Stimulator For Adhd2Product Code
- QGTDistal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine2Product Code
- QJQCranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety2Product Code
- QMZDigital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions2Product Code
- QQCBrain Stimulation Programming Planning Software.2Product Code
- OVPVibratory Counter-Stimulation2Product Code
- QVOComputerized Behavioral Therapy Device For Insomnia2Product Code
- SAPComputerized Behavioral Therapy Device For Depressive Disorders.2Product Code
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
i-ED COIL
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K192068
- 510(k) Type
- Traditional
- Applicant
- Kaneka Pharma America LLC
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/25/2020
- Days to Decision
- 268 days
- Submission Type
- Summary