FDA Review Panel · NE

FDA 510(k) Neurology Devices

FDA 510(k) Neurology Devices - Regulatory Overview

FDA 510(k) neurology devices cover diagnostic and therapeutic equipment for the nervous system. The FDA review panel code is NE.

Common categories include:

  • EEG and neurophysiology systems - electroencephalographs, EMG, nerve conduction
  • Neurostimulators - transcranial magnetic stimulation (TMS), vagus nerve stimulation
  • Surgical navigation systems - image-guided neurosurgery platforms
  • Intracranial pressure monitors - ICP sensors and drainage systems
  • Neuroendoscopes - rigid and flexible scopes for minimally invasive neurosurgery

6291
Total
6236
Cleared
153d
Avg (2y)
1976
Since
4744 Neurology devices
3001–3025 of 4744
Cleared Aug 20, 2004
BODY CLOCK STIMPLUS AND STIMPLUS PRO
K041359 · Body Clock Health Care, Ltd.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 91d
Cleared Aug 20, 2004
MICRO-RECORDING AND STIMULATION ELECTRODES-MICRO MACROELECTRODE MODEL NO. 230700-230799
K041409 · Inomed GmbH
GZL · Electrode, Depth · 85d
Cleared Aug 16, 2004
MACRO-MICRO DEPTH ELECTRODE
K041604 · Ad-Tech Medical Instrument Corp
GZL · Electrode, Depth · 63d
Cleared Aug 12, 2004
POLYGRAM NET BIOFEEDBACK APPLICATION
K041244 · Medtronic Vascular
HCC · Device, Biofeedback · 93d
Cleared Aug 12, 2004
MODIFICATION TO NC-STAT
K041320 · Neurometrix, Inc.
JXE · Device, Nerve Conduction Velocity Measurement · 86d
Cleared Aug 11, 2004
MERCI RETRIEVER, MODELS 90065, 90066
K033736 · Concentric Medical, Inc.
NRY · Catheter, Thrombus Retriever · 257d
Cleared Aug 10, 2004
ELEKTA OY
K041264 · Elekta Neuromag OY
OLX · Source Localization Software For Electroencephalograph Or Magnetoencephalograph · 90d
Cleared Aug 09, 2004
VERSASTIM, PERFOAMAX, SURGI-STIM, FASTSTART
K041953 · Conmedcorp
GXY · Electrode, Cutaneous · 20d
Cleared Aug 06, 2004
XLTEK PROTEKTOR STIMULATOR, MODELS 10247 & 10248
K040358 · Excel Tech. , Ltd.
GWF · Stimulator, Electrical, Evoked Response · 175d
Cleared Aug 03, 2004
PMT SPHENOIDAL ELECTRODE AND ACCESSORY, MODEL 2101-31 AND 2102-31 SERIES
K033730 · Pmt Corp.
GZL · Electrode, Depth · 249d
Cleared Aug 03, 2004
NEUROGUIDE ANALYSIS SYSTEM
K041263 · Applied Neuroscience, Inc.
OLU · Normalizing Quantitative Electroencephalograph Software · 84d
Cleared Jul 29, 2004
NEURO-ENDOSCOPE SYSTEM BY HOPF, EXISTING OF: ENDOSCOPES, SHEATHS, WORKING ELEMENTS, BIPOLAR AND UNIPOLAR ELECTRODES
K031858 · Richard Wolf Medical Instruments Corp.
GWG · Endoscope, Neurological · 409d
Cleared Jul 27, 2004
DUREPAIR DURA REGENERATION MATRIX
K041000 · Medtronic Neurosurgery
GXQ · Dura Substitute · 99d
Cleared Jul 23, 2004
ELEKTA MICRODRIVE, MODEL 916716
K040979 · Elekta Instrument AB
HAW · Neurological Stereotaxic Instrument · 99d
Cleared Jul 16, 2004
FENZIAN TREATMENT SYSTEM
K041575 · Eumedic Limited
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 32d
Cleared Jul 16, 2004
NEURA WRAP NERVE PROTECTOR
K041620 · Integra Lifesciences Corp.
JXI · Cuff, Nerve · 30d
Cleared Jul 16, 2004
SAPPHIRE NXT DETACHABLE COIL SYSTEM
K041649 · Micro Therapeutics, Inc.
HCG · Device, Neurovascular Embolization · 29d
Cleared Jul 08, 2004
ACUMEN SURGICAL NAVIGATION SYSTEM
K031454 · Biomet, Inc.
HAW · Neurological Stereotaxic Instrument · 428d
Cleared Jul 08, 2004
SYNTHES (USA) CHRONOS
K041350 · Synthes (Usa)
GXP · Methyl Methacrylate For Cranioplasty · 49d
Cleared Jul 07, 2004
INTERFERENTIAL STIMULATOR, MODEL BMLS02-6
K040007 · Biomedical Life Systems, Inc.
LIH · Interferential Current Therapy · 187d
Cleared Jul 07, 2004
MODIFICATION TO: HYDROCOIL EMBOLIC SYSTEM (HES)
K041551 · MicroVention, Inc.
HCG · Device, Neurovascular Embolization · 28d
Cleared Jul 06, 2004
BIS PEDIATRIC SENSOR
K041670 · Aspect Medical Systems, Inc.
GXY · Electrode, Cutaneous · 15d
Cleared Jul 01, 2004
EASYNET BODY POSITION MODULE
K040932 · Cadwell Laboratories, Inc.
LEL · Device, Sleep Assessment · 83d
Cleared Jul 01, 2004
CADWELL LIMB MOVEMENT MODULE
K040986 · Cadwell Laboratories, Inc.
LEL · Device, Sleep Assessment · 77d
Cleared Jul 01, 2004
FAST START TENS, MODEL FS 3001
K041092 · Vision Quest Industries, Inc.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 66d

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All categories 4744 HAW Neurological Stereotaxic Instrument 342 GXY Electrode, Cutaneous 307 GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief 279 JXG Shunt, Central Nervous System And Components 224 NUH Stimulator, Nerve, Transcutaneous, Over-the-counter 211 HCG Device, Neurovascular Embolization 173 GWQ Full-montage Standard Electroencephalograph 142 NRY Catheter, Thrombus Retriever 114 GZB Stimulator, Spinal-cord, Implanted (pain Relief) 113 GWF Stimulator, Electrical, Evoked Response 100 QJP Catheter, Percutaneous, Neurovasculature 97 GWG Endoscope, Neurological 87 NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes 74 GWM Device, Monitoring, Intracranial Pressure 71 OBP Transcranial Magnetic Stimulator 67