FDA Device Explorer

Neurology (NE) FDA Submissions

Browse FDA 510(k), De Novo, and PMA medical device clearances for the Neurology (NE) review panel, including product codes, regulations, and cleared devices.

CFR Parts: Part 882, Part 890

Subparts

Product Codes

Product CodeDevice NameRegulationClassDevices
GZMAnalyzer, Rigidity882.102020
GWWAtaxiagraph882.103010
PTBAtaxiagraph With Interpretive Software882.103010
GWIDiscriminator, Two-Point882.120012
LLNDevice, Vibration Threshold Measurement882.1200113
LQWTest, Temperature Discrimination882.120013
GXWEchoencephalograph882.124027
GYBMedia, Electroconductive882.1275269
GYCElectrode, Cortical882.1310232
GXYElectrode, Cutaneous882.13202432
GZLElectrode, Depth882.1330258
GZKElectrode, Nasopharyngeal882.134022
GXZElectrode, Needle882.1350253
SEMSub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring882.136021
GWQFull-Montage Standard Electroencephalograph882.14002188
OLTNon-Normalizing Quantitative Electroencephalograph Software882.1400254
OLUNormalizing Quantitative Electroencephalograph Software882.1400212
OLVStandard Polysomnograph With Electroencephalograph882.1400264
OLWIndex-Generating Electroencephalograph Software882.1400238
OLXSource Localization Software For Electroencephalograph Or Magnetoencephalograph882.1400224
OLYMagnetoencephalograph882.140026
OLZAutomatic Event Detection Software For Polysomnograph With Electroencephalograph882.1400236
OMAAmplitude-Integrated Electroencephalograph882.1400216
OMBAutomatic Event Detection Software For Full-Montage Electroencephalograph882.1400241
OMCReduced- Montage Standard Electroencephalograph882.1400228
ORTBurst Suppression Detection Software For Electroencephalograph882.140021
SFKRespiratory Effort Belt For Polysomnography882.140021
GYATester, Electrode/Lead, Electroencephalograph882.141015
GWSAnalyzer, Spectrum, Electroencephalogram Signal882.1420115
GWRGenerator, Electroencephalograph Test Signal882.143010
NCGNeuropsychiatric Interpretative Electroencephalograph Assessment Aid882.144023
PIWBrain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid882.145029
QWTPrognostic Assessment Software Of Mild Cognitive Impairment882.145421
QEABrain Injury Adjunctive Interpretive Oculomotor Assessment Aid882.145526
GWNNystagmograph882.1460259
PKQComputerized Cognitive Assessment Aid882.147023
PTYComputerized Cognitive Assessment Aid, Exempt882.147020
POMComputerized Cognitive Assessment Aid For Concussion882.147128
SGBPain Assessment Software In Non-Communicative Adults882.147221
GWGEndoscope, Neurological882.1480291
QPFPediatric Autism Spectrum Disorder Diagnosis Aid882.149126
GXBEsthesiometer882.150017
GWXFork, Tuning882.152514
GZODevice, Galvanic Skin Response Measurement882.1540226
JXEDevice, Nerve Conduction Velocity Measurement882.1550227
HCJDevice, Skin Potential Measurement882.156022
PNAEvoked Photon Image Capture Device882.156111
QSLBrain Temperature Measurement System882.156521
HCSDevice, Temperature Measurement, Direct Contact, Powered882.157028
POSPhysiological Signal Based Seizure Monitoring System882.1580210
GXSMonitor, Alpha882.161020
GWMDevice, Monitoring, Intracranial Pressure882.16202105
PSPIntracranial Pressure & Temperature Monitoring Kit882.162020
POPCranial Motion Measurement Device882.163022
GWZPercussor882.1700111
GWYPinwheel882.175015
PVPNeurological Test Kit882.175010
JXFPlethysmograph, Ocular882.179030
GZNRheoencephalograph882.182530
GWLAmplifier, Physiological Signal882.1835253
GWKConditioner, Signal, Physiological882.1845223
GYEEncephalogram Telemetry System882.1855220
SFNNon-Invasive Evoked Response Brain Stimulator882.186021
GWFStimulator, Electrical, Evoked Response882.18702139
NTUEvoked Potential Stimulator, Thermal882.187023
SDXNeuromuscular Stimulator And Exercise Evaluation System882.187121
GZPStimulator, Mechanical, Evoked Response882.188022
GWEStimulator, Photic, Evoked Response882.1890249
GWJStimulator, Auditory, Evoked Response882.1900276
GXXBlock, Test, Ultrasonic Scanner Calibration882.192513
GYDTransducer, Tremor882.1950212
SHOParkinsonian Syndrome Diagnostic Aid882.200021
GXMAnvil, Skull Plate882.403010
HCDCannula, Ventricular882.406013
HCACatheter, Ventricular882.4100210
NHCCatheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents)882.410023
PVMEndoscopic Ventricular Catheter Placement Kit882.410020
SDGBrain Intraparenchymal Infusion Cannula882.411021
HBNChair, Neurosurgical882.412514
HBOClip, Scalp882.4150210
HCIApplier, Aneurysm Clip882.4175214
HBSInstrument, Clip Forming/Cutting882.419010
NMNInstrument, Clip, Forming/Cutting, Reprocessed882.419010
HBQInstrument, Clip Removal882.420010
HBRRack, Clip882.421511
GXHDevice, Surgical, Cryogenic882.4250223
GZQInstrument, Dowel Cutting882.427521
HBGDrills, Burrs, Trephines & Accessories (Manual)882.4300217
NLODrills, Burrs, Trephines And Accessories (Manual), Reprocessed882.430020
HBFDrills, Burrs, Trephines & Accessories (Compound, Powered)882.4305218
NLPDrills, Burrs, Trephines, And Accessories (Powered Compound), Reprocessed882.430520
HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)882.4310265
NLNDrills, Burrs, Trephines And Accessories (Simple Powered), Reprocessed882.431021
PPTCranial Surgical Planning And Instrument Guides882.431024
HBDHandpiece (Brace), Drill882.432510
HBCMotor, Drill, Electric882.4360226
HBBMotor, Drill, Pneumatic882.4370227
GXDGenerator, Lesion, Radiofrequency882.4400237
SGNHigh Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation882.442021
HBMHeadrest, Neurosurgical882.444013
HBLHolder, Head, Neurosurgical (Skull Clamp)882.4460250
HBXInstrument, Cranioplasty Material Forming882.450010
GZXInstrument, Microsurgical882.4525113
OJGNeurological Tray882.452510
HAOInstrument, Surgical, Non-Powered882.4535134
GYKInstrument, Shunt System Implantation882.4545113
PIYStainless Steel Instrument, Shunt System Implantation882.454510
HAWNeurological Stereotaxic Instrument882.45602422
OEWTracking, Soft Tissue, Intraoperative882.456024
OJPOrthopedic Computer Controlled Surgical System882.456024
OLOOrthopedic Stereotaxic Instrument882.45602423
ONAComputer Assisted Hair Harvesting System882.456024
ONNIntraoperative Orthopedic Joint Assessment Aid882.4560216
ORRNeurological Stereotaxic Instrument, Real-Time Intraoperative Mri882.456024
OSEPatient Specific Manual Navigation System882.456020
OSFPatient Specific Manual Orthopedic Stereotaxic System882.456023
PGWEar, Nose, And Throat Stereotaxic Instrument882.4560236
QRISurgical Planning Software For Neurological Stereotaxic Instruments882.456021
SBFOrthopedic Augmented Reality882.4560241
SGEExtracranial Positional System For A Transcranial Magnetic Stimulation System882.456021
QLVField Generator Positioning Device882.456510
GXELeukotome882.460011
HASNeedle, Neurosurgical Suture882.465010
HBANeurosurgical Paddie882.4700224
GXIProbe, Radiofrequency Lesion882.4725266
GXJPunch, Skull882.475010
GZTRetractor, Self-Retaining, For Neurosurgery882.4800243
HAERongeur, Manual882.4840236
HADRongeur, Powered882.484523
GXLScrewdriver, Skullplate882.490010
QFXDiagnostic Neurosurgical Microscope Filter882.495025
JXHMethyl Methacrylate For Aneurysmorrhaphy882.503023
HCCDevice, Biofeedback882.50502172
LELDevice, Sleep Assessment882.5050219
SENBiofeedback For Adjunctive Treatment Of Symptoms Associated With Stress And Anxiety882.505021
OBVEating Disorder Conditioning Tool882.506021
JXLBlock, Bite882.5070228
HBZCatheter, Intravascular Occluding882.515030
NUFCatheter, Neurovasculature, Occluding Balloon882.515030
PAVCatheter, Neuro-Vasculature, Occluding Balloon882.5150f0
HCEClamp, Carotid Artery882.517522
HCHClip, Aneurysm882.5200236
HBPClip, Implanted Malleable882.522520
HCBDevice, Aversive Conditioning882.523526
GXRCover, Burr Hole882.5250229
SBGIn Situ Polymerizing Peripheral Nerve Cap882.526022
SFDIn Situ Polymerizing Peripheral Nerve Repair Device882.527022
JXICuff, Nerve882.5275240
GXPMethyl Methacrylate For Cranioplasty882.5300243
MYUAccessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty882.530026
GWOPlate, Cranioplasty, Preformed, Alterable882.5320242
PJMFiller, Bone Void, Alterable Compound For Cranioplasty882.532020
GXNPlate, Cranioplasty, Preformed, Non-Alterable882.5330255
PBJCranial Distraction System882.533026
PJNFiller, Bone Void, Non-Alterable Compound For Cranioplasty882.533022
HBWFastener, Plate, Cranioplasty882.536027
GXTMonitor, Lesion Temperature882.550020
JXGShunt, Central Nervous System And Components882.55502258
LKGPort & Catheter, Implanted, Subcutaneous, Intraventricular882.555028
PVLEndoscopic Shunt Placement Kit882.555020
PVOLumbar Drainage Catheter Kit882.555020
PCBExternal Cerebrospinal Fluid (Csf) Diversion882.556022
POLNeurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment882.5600218
PLUThermal System For Insomnia882.570021
QMZDigital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions882.570521
JXKCranial Electrotherapy Stimulator To Treat Depression882.580032
QJQCranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety882.5800219
PWEComputerized Behavioral Therapy Device For Substance Use Disorders882.580122
QVOComputerized Behavioral Therapy Device For Insomnia882.580122
SAPComputerized Behavioral Therapy Device For Depressive Disorders.882.580122
SCPComputerized Behavioral Therapy Device For Anxiety Disorders882.580121
QCITranscranial Magnetic Stimulation System For Obsessive-Compulsive Disorder882.580229
QMDTranscranial Magnetic Stimulation System For Smoking Cessation882.580222
QWIComputerized Behavioral Therapy Device For The Treatment Of Fibromyalgia Symptoms882.580421
OBPTranscranial Magnetic Stimulator882.5805264
QFFElectromechanical Arm For A Transcranial Magnetic Stimulation System882.580521
SEEComputerized Behavioral Therapy Device For Migraine882.580621
OKPTranscranial Magnetic Stimulator For The Treatment Of Migraine Headache882.580826
GZIStimulator, Neuromuscular, External Functional882.5810261
GZAImplanted Cerebellar Stimulator882.582030
GZEImplanted Diaphragmatic/Phrenic Nerve Stimulator882.583031
GYZStimulator, Intracerebral/Subcortical, Implanted882.584030
GZDStimulator, Spinal-Cord, Implanted, For Bladder Evacuation882.585030
QQCBrain Stimulation Programming Planning Software.882.585523
GZCStimulator, Neuromuscular, Implanted882.586031
GZFStimulator, Peripheral Nerve, Implanted (Pain Relief)882.5870225
GZBStimulator, Spinal-Cord, Implanted (Pain Relief)882.58802139
LHGElectrode, Spinal Epidural882.588021
QWDStimulator, Nerve, For Restless Legs Syndrome882.588721
QSQTranscutaneous Electrical Nerve Stimulator To Treat Fibromyalgia Symptoms882.588821
QCFElectrical Tongue Stimulator To Treat Motor Deficits882.588921
GZJStimulator, Nerve, Transcutaneous, For Pain Relief882.58902605
LIHInterferential Current Therapy882.5890273
NFOStimulator, Transcutaneous Electrical, Aesthetic Purposes882.5890275
NHIStimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief882.5890213
NUHStimulator, Nerve, Transcutaneous, Over-The-Counter882.58902227
NYNStimulator, Electrical, Transcutaneous, For Arthritis882.589028
NYWStimulator, Nerve, Electrical, Transcutaneous, With Limited Output, For Pain Relief882.589020
NYXStimulator, Electrical, Transcutaneous, With Limited Output, For Aesthetic Purposes882.589020
OCFStimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthritis Pain Relief882.589021
QFDTens For Sinus Pain882.589020
QPLElectromagnetic Stimulator, Pain Relief882.589026
PCCStimulator, Nerve, Electrical, Transcutaneous, For Migraine882.5891218
PKRNon-Invasive Vagus Nerve Stimulator - Headache882.589229
QAKNon-Invasive Vagus Nerve Stimulator For Migraine Headache882.589220
QARThermal Vestibular Stimulator For Headache882.589321
OSGPiezo-Electric Stimulator For Relief Of Mosquito Bite Itch882.589422
PZRPercutaneous Nerve Stimulator For Opioid Withdrawal882.589628
QBCExternal Upper Limb Tremor Stimulator882.589729
QGLTranscutaneous Nerve Stimulator For Adhd882.589825
QGTDistal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine882.589927
GXOStrip, Craniosynostosis, Preformed882.590022
GXQDura Substitute882.5910243
GXCDevice, Electroconvulsive Therapy882.594030
QGHElectroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder882.594029
HCGDevice, Neurovascular Embolization882.59502184
MZQBalloon, Detachable, For Neurovascular Occlusion882.595022
PUUTemporary Coil Embolization Assist Device882.595521
HAXTong, Skull For Traction882.5960220
MVAOrthosis, Cranial882.5970243
OANOrthosis, Cranial, Laser Scan882.5970223
LEMHuman Lyophilized Dura Mater882.597522
QNXExternal Compression Device For Internal Jugular Vein Compression890.305021
QOLElectroencephalography (Eeg)-Driven Upper Extremity Powered Exerciser890.542021
QRAVirtual Reality Behavioral Therapy Device For Pain Relief890.580026
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