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
4737 Neurology devices
2851–2875 of 4737
Cleared Sep 16, 2005
NEURODRIVE SYSTEM
K051830 · Alpha Omega , Ltd.
GZL · Electrode, Depth · 72d
Cleared Sep 14, 2005
SINGLE AMPLIFIER FOR BOTOX
K051852 · Allergan, Inc.
GWL · Amplifier, Physiological Signal · 68d
Cleared Sep 14, 2005
DUREPAIR DURA REGENERATION MATRIX
K052211 · Medtronic Neurosurgery
GXQ · Dura Substitute · 30d
Cleared Sep 12, 2005
COGNITRACE
K051825 · Eemagine Medical Imaging Solutions GmbH
GWQ · Full-montage Standard Electroencephalograph · 69d
Cleared Sep 09, 2005
BIS EEG MONITOR, MODEL A-3000
K052362 · Aspect Medical Systems, Inc.
OLW · Index-generating Electroencephalograph Software · 11d
Cleared Sep 08, 2005
SPINEASSIST DEVICE WITH ADDITIONAL ACCESSORIES
K051676 · Mazor Surgical Technologies , Ltd.
HAW · Neurological Stereotaxic Instrument · 77d
Cleared Sep 07, 2005
BIO-STIM KIT
K050174 · Skylark Device & Systems Co., Ltd.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 225d
Cleared Sep 06, 2005
E-STIM II
K050435 · Lhasa Oms, Inc.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 196d
Cleared Sep 02, 2005
SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECTROSE SET
K051874 · Physiometrix, Inc.
OLW · Index-generating Electroencephalograph Software · 53d
Cleared Aug 31, 2005
OPTI-AMP DC-POWERED
K052060 · Intelligent Hearing Systems
GWL · Amplifier, Physiological Signal · 33d
Cleared Aug 26, 2005
CEEGRAPH/SLEEPSCAN NETLINK TRAVELER
K052066 · Bio-Logic Systems Corp.
OLV · Standard Polysomnograph With Electroencephalograph · 25d
Cleared Aug 23, 2005
DATEX-OHMEDA S/5 BIS MODULE, E-BIS AND ACCESSORIES
K052145 · Ge Healthcare
OLW · Index-generating Electroencephalograph Software · 15d
Cleared Aug 23, 2005
CUTANEOUS ELECTRODE
K052188 · Rhythmlink International, LLC
GXY · Electrode, Cutaneous · 12d
Cleared Aug 17, 2005
MEE-1000A NEUROMASTER
K051178 · Nihon Kohden America, Inc.
GWF · Stimulator, Electrical, Evoked Response · 100d
Cleared Aug 17, 2005
RESOLVE OPEN BACK HALO RINGS
K051918 · Jerome Medical
HAX · Tong, Skull For Traction · 33d
Cleared Aug 17, 2005
XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 102382
K052111 · Excel Tech. , Ltd.
GXZ · Electrode, Needle · 13d
Cleared Aug 15, 2005
ECLIPSE NEUROLOGICAL WORKSTATION
K050798 · Axon Systems, Inc.
GWF · Stimulator, Electrical, Evoked Response · 139d
Cleared Aug 05, 2005
DATEX-OHMEDA S/5 EEG MODULE, E-EEG AND DATEX-OHMEDA S/5 EEG HEADBOX, N-EEG AND ACCESSORIES.
K051883 · Ge Healthcare
OLT · Non-normalizing Quantitative Electroencephalograph Software · 24d
Cleared Aug 04, 2005
AMBU NEUROLINE GROUND
K051529 · Ambu, Inc.
GXY · Electrode, Cutaneous · 56d
Cleared Jul 28, 2005
MODEL 3873 1* 8 AND MODEL 3874 1* 8 COMPACT TEST STIMULATION LEADS
K051773 · Medtronic Inc.,Neurological Division.
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 27d
Cleared Jul 27, 2005
MEDTRONIC ORTHOPAEDIC TRAUMA APPLICATION
K050651 · Medtronic Navigation, Inc.
HAW · Neurological Stereotaxic Instrument · 135d
Cleared Jul 19, 2005
NEURORECOVERY, INC. (NRI) COMPREHENSIVE INTRACRANIAL PRESSURE EVALUATION AND RELIEF (CIPER) KIT
K051599 · Neurorecovery, Inc.
GWM · Device, Monitoring, Intracranial Pressure · 33d
Cleared Jul 19, 2005
ACUMEN IMAGE GUIDED SURGICAL SYSTEM
K051724 · Ebi, L.P.
HAW · Neurological Stereotaxic Instrument · 22d
Cleared Jul 18, 2005
CODMAN VPV SYSTEM, MODEL 82-3192
K050739 · Codman & Shurtleff, Inc.
JXG · Shunt, Central Nervous System And Components · 119d
Cleared Jul 15, 2005
THE ODFS DROPPED FOOT STIMULATOR
K050991 · Department of Medical Physics and Biomedical Eng.
GZI · Stimulator, Neuromuscular, External Functional · 87d

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All categories 4737 HAW Neurological Stereotaxic Instrument 342 GXY Electrode, Cutaneous 307 GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief 279 JXG Shunt, Central Nervous System And Components 223 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