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
4732 Neurology devices
2726–2750 of 4732
Cleared Aug 25, 2006
MICRUS MICROCOIL SYSTEM PRESIDIO-18, MODEL PC4
K062036 · Micrus Endovascular Corporation
HCG · Device, Neurovascular Embolization · 37d
Cleared Aug 21, 2006
VECTORVISION HIP
K060727 · Brainlab AG
HAW · Neurological Stereotaxic Instrument · 157d
Cleared Aug 21, 2006
UNI KNEE SURGETICS NAVIGATION SYSTEM
K062146 · Praxim S.A
HAW · Neurological Stereotaxic Instrument · 25d
Cleared Aug 16, 2006
ACUBAND ACUPRESSURE WRIST BAND DEVICE
K053509 · Acuband, Inc.
MVV · Device, Acupressure · 243d
Cleared Aug 16, 2006
MODEL 3875 1 X 8 SC TEST STIMULATION LEAD
K062041 · Medtronic, Inc.
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 28d
Cleared Aug 15, 2006
DEEPWAVE PERCUTANEOUS NEUROMODULATION PAIN THERAPY SYSTEM
K061166 · Biowave Corporation
NHI · Stimulator, Nerve, Electrical, Percutaneous (pens), For Pain Relief · 110d
Cleared Aug 14, 2006
XLTEK CLEAN SIGNAL ADHESIVE ELECTRODES
K061269 · Excel Tech. , Ltd.
GXY · Electrode, Cutaneous · 101d
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

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All categories 4732 HAW Neurological Stereotaxic Instrument 342 GXY Electrode, Cutaneous 307 GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief 278 JXG Shunt, Central Nervous System And Components 222 NUH Stimulator, Nerve, Transcutaneous, Over-the-counter 211 HCG Device, Neurovascular Embolization 173 GWQ Full-montage Standard Electroencephalograph 141 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