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
4750 Neurology devices
3376–3400 of 4750
Cleared Oct 15, 1999
CODMAN SINGLE AND DOUBLE LUMEN SKULL BOLT KITS
K992591 · Codman & Shurtleff, Inc.
GWM · Device, Monitoring, Intracranial Pressure · 74d
Cleared Oct 14, 1999
NEUROFAX, MODEL EEG-1100A
K992742 · Nihon Kohden America, Inc.
OLV · Standard Polysomnograph With Electroencephalograph · 59d
Cleared Oct 08, 1999
VIEWPOINT ENT/ORTHOPEDIC OPTION
K991256 · Philips Medical Systems (Cleveland), Inc.
HAW · Neurological Stereotaxic Instrument · 178d
Cleared Sep 24, 1999
LEKSELL IMAGE GUIDANCE SURGICAL SYSTEM, VIEW SCOPE, SURGISCOPE,ELEKTA INSIGHT
K992882 · Elekta Instrument AB
HAW · Neurological Stereotaxic Instrument · 29d
Cleared Sep 24, 1999
RENEW RECEIVER
K992946 · Advanced Neuromodulation Systems
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 23d
Cleared Sep 23, 1999
NMT NEUROSCIENCES CONTROL UNIT, MODEL 910-600 & NMT NEUROSCIENCES DISPOSABLE DRAINAGE LINE KIT, MODEL 910-6XX
K990660 · Nmt Neurosciences Implants S.A.
JXG · Shunt, Central Nervous System And Components · 206d
Cleared Sep 21, 1999
MINI-LOGGER SERIES 2000
K991045 · Mini-Mitter Co., Inc.
GWK · Conditioner, Signal, Physiological · 176d
Cleared Sep 21, 1999
RADIONICS MICROELECTRODE KIT
K991399 · Radionics, Inc.
GXI · Probe, Radiofrequency Lesion · 152d
Cleared Sep 17, 1999
TENS/FES/NMES ELECTRODES
K983097 · Uni-Patch, Inc.
GXY · Electrode, Cutaneous · 389d
Cleared Sep 17, 1999
@ TARGET
K983410 · Brainlab AG
HAW · Neurological Stereotaxic Instrument · 354d
Cleared Sep 17, 1999
PHAZX VLD-100
K992129 · Phazx Systems, Inc.
GZO · Device, Galvanic Skin Response Measurement · 86d
Cleared Sep 14, 1999
BIO-LOGIC EVOKED POTENTIAL FOR ABAER I
K992807 · Bio-Logic Systems Corp.
GWJ · Stimulator, Auditory, Evoked Response · 25d
Cleared Sep 13, 1999
CORTICAL MAPPING UNIT, MODEL CMU
K992194 · Ad-Tech Medical Instrument Corp
GYC · Electrode, Cortical · 76d
Cleared Sep 10, 1999
COSMAN ROBERT WELLS FUNCTIONAL PROBE MICRODRIVE
K992721 · Radionics, Inc.
HAW · Neurological Stereotaxic Instrument · 28d
Cleared Sep 08, 1999
RADIONICS XDC EXTERNAL VENTRICULAR CATHETER
K992379 · Radionics, Inc.
JXG · Shunt, Central Nervous System And Components · 54d
Cleared Sep 01, 1999
NIHON KOHDEN MEB-2200A NEUROPACK EVOKED POTENTIAL & EMG MEASURING SYSTEM WITH ACCESSORIES
K991899 · Nihon Kohden America, Inc.
GWF · Stimulator, Electrical, Evoked Response · 89d
Cleared Aug 27, 1999
CERSR ELECTROMYOGRAPHY SYSTEM
K990766 · Paraspinal Diagnostic Corp.
IKN · Electromyograph, Diagnostic · 172d
Cleared Aug 27, 1999
MITAKA POINT SETTER
K991989 · Mitaka USA, Inc.
GWG · Endoscope, Neurological · 74d
Cleared Aug 27, 1999
ARTISAN ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY
K992283 · Airsep Corp.
OLV · Standard Polysomnograph With Electroencephalograph · 51d
Cleared Aug 27, 1999
NAVIGUS TRAJECTORY GUIDE, MODEL TG-XXXX
K992304 · Image-Guided Neurologics, Inc.
HAW · Neurological Stereotaxic Instrument · 50d
Cleared Aug 27, 1999
SNN SYSTEM WITH OLIVIER DOUBLE CHUCK SUPPORT ARM OPTION
K992457 · Surgical Navigation Specialists, Inc.
HAW · Neurological Stereotaxic Instrument · 35d
Cleared Aug 19, 1999
ELECTRO-NERVE STIMULATOR TENS, MODEL LX
K990230 · Biomedical Life Systems, Inc.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 206d
Cleared Aug 19, 1999
XL TEK EVOKED POTENTIAL HEADBOX, MODEL EP-16
K992313 · Excel Tech. , Ltd.
GWF · Stimulator, Electrical, Evoked Response · 41d
Cleared Aug 18, 1999
CUTANEOUS (BAR) ELECTRODE
K991769 · Neuro Supplies, Inc.
GXY · Electrode, Cutaneous · 86d
Cleared Aug 18, 1999
CUTANEOUS (GROUND) ELECTRODE
K991770 · Neuro Supplies, Inc.
GXY · Electrode, Cutaneous · 86d

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All categories 4750 HAW Neurological Stereotaxic Instrument 342 GXY Electrode, Cutaneous 307 GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief 281 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 101 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