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

6334
Total
6279
Cleared
155d
Avg (2y)
1976
Since
6334 Neurology devices
2901–2925 of 6334
Cleared Aug 04, 2006
STRYKER ORTHOPAEDICS RFID INSTRUMENTATION
K053348 · Howmedica Osteonics Corp.
HAW · Neurological Stereotaxic Instrument · 245d
Cleared Jul 31, 2006
BRIGIT SURGICAL DEVICE
K060556 · Zimmer, Inc.
HAW · Neurological Stereotaxic Instrument · 151d
Cleared Jul 31, 2006
NC-STAT
K060584 · Neurometrix, Inc.
JXE · Device, Nerve Conduction Velocity Measurement · 146d
Cleared Jul 27, 2006
INTEGRA MOBIUS MULTI-MODALITY MONITORING SYSTEM
K061640 · Integra LifeSciences Corporation
GWM · Device, Monitoring, Intracranial Pressure · 45d
Cleared Jul 26, 2006
VYCOR SURGICAL ACCESS SYSTEMS
K060973 · Vycor Medical, LLC
GZT · Retractor, Self-retaining, For Neurosurgery · 107d
Cleared Jul 26, 2006
ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS06-1
K061476 · Biomedical Life Systems, Inc.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 57d
Cleared Jul 25, 2006
BRAINPRO, BRAINPRO ACCESS
K060808 · PAJUNK GmbH Medizintechnologie
HAW · Neurological Stereotaxic Instrument · 123d
Cleared Jul 14, 2006
COLLAGEN NERVE WRAP
K060952 · Collagen Matrix, Inc.
JXI · Cuff, Nerve · 99d
Cleared Jul 11, 2006
MINOP DISPOSABLE INTRODUCER 10F, MODEL ME010
K061135 · Aesculap
GWG · Endoscope, Neurological · 78d
Cleared Jul 11, 2006
FOCUS VNG/ENG TYPE 1068
K061791 · Gn Otometrics A/S
GWN · Nystagmograph · 15d
Cleared Jul 07, 2006
NESS L300
K053468 · Ness-Neuromuscular Electrical Stimulation Systems
GZI · Stimulator, Neuromuscular, External Functional · 206d
Cleared Jun 26, 2006
DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE - ONLAY AND SUTURABLE
K061487 · Collagen Matrix, Inc.
GXQ · Dura Substitute · 26d
Cleared Jun 23, 2006
EMJOI TENS DEVICE
K052711 · Emjoi, Inc.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 267d
Cleared Jun 23, 2006
SPACELABS MEDICAL BISPECTRAL INDEX (BISX) ANALYSIS MODULE 91482 AND ACCESSORIES MODEL-91842
K060900 · Spacelabs Medical, Inc.
OLW · Index-generating Electroencephalograph Software · 81d
Cleared Jun 23, 2006
SMART USBLITE, MODEL M011120
K061443 · Intelligent Hearing Systems
GWJ · Stimulator, Auditory, Evoked Response · 30d
Cleared Jun 19, 2006
POINTER PLUS
K060508 · Lhasa Oms, Inc.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 112d
Cleared Jun 19, 2006
POINTER EXCEL
K060517 · Lhasa Oms, Inc.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 112d
Cleared Jun 15, 2006
SNAP II EEG MONITOR
K060997 · Everest Biomedical Instruments Co.
OLW · Index-generating Electroencephalograph Software · 66d
Cleared Jun 06, 2006
VECTORVISION SPINE
K053159 · Brainlab AG
HAW · Neurological Stereotaxic Instrument · 204d
Cleared May 31, 2006
INSPIRSTAR GLOVE ELECTRODE
K061343 · Inspirstar, Inc.
GXY · Electrode, Cutaneous · 16d
Cleared May 30, 2006
DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRAOPERATIVE SUBDURAL ELECTRODES
K053363 · Ad-Tech Medical Instrument Corp
GYC · Electrode, Cortical · 179d
Cleared May 30, 2006
PEDIATRIC SUBDERMAL WIRE ELECTRODE (PSWE)
K060189 · Ives Eeg Solutions, Inc.
GXZ · Electrode, Needle · 126d
Cleared May 30, 2006
REFA, PHYSIOLOGICAL AMPLIFIER
K060374 · Tms International BV
GWL · Amplifier, Physiological Signal · 106d
Cleared May 25, 2006
DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECTRODES
K053358 · Ad-Tech Medical Instrument Corp
GZL · Electrode, Depth · 174d
Cleared May 25, 2006
MODIFIED MERCI RETRIEVER, MODEL 90092
K061059 · Concentric Medical, Inc.
NRY · Catheter, Thrombus Retriever · 38d

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All categories 6334 GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief 605 GXY Electrode, Cutaneous 438 HAW Neurological Stereotaxic Instrument 417 JXG Shunt, Central Nervous System And Components 260 NUH Stimulator, Nerve, Transcutaneous, Over-the-counter 218 GWQ Full-montage Standard Electroencephalograph 189 HCG Device, Neurovascular Embolization 187 HCC Device, Biofeedback 172 GWF Stimulator, Electrical, Evoked Response 140 GZB Stimulator, Spinal-cord, Implanted (pain Relief) 133 NRY Catheter, Thrombus Retriever 117 GWM Device, Monitoring, Intracranial Pressure 105 QJP Catheter, Percutaneous, Neurovasculature 102 GWG Endoscope, Neurological 94 NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes 81