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
1851–1875 of 6334
Cleared Dec 22, 2015
ALEVE Direct Therapy (ALEVE Direct Therapy TENS device)
K152852 · Bayer Healthcare, LLC
NUH · Stimulator, Nerve, Transcutaneous, Over-the-counter · 84d
Cleared Dec 18, 2015
LiquoGuard 7, LiquoGuard 7 Drainage Set, Lenght 2000mm
K150898 · Moller Medical GmbH
JXG · Shunt, Central Nervous System And Components · 260d
Cleared Dec 18, 2015
ROSA Brain
K151359 · Medtech S.A
HAW · Neurological Stereotaxic Instrument · 212d
Cleared Dec 16, 2015
Counter OTC TENS Device, Model CSD-737Z
K151279 · Counter Scientific Development (Gz), Ltd.
NUH · Stimulator, Nerve, Transcutaneous, Over-the-counter · 216d
Cleared Dec 02, 2015
Reaxon Plus
K143711 · Medovent GmbH
JXI · Cuff, Nerve · 338d
Cleared Nov 25, 2015
SonicLift
K150077 · Pretika Corporation
NFO · Stimulator, Transcutaneous Electrical, Aesthetic Purposes · 315d
Cleared Nov 23, 2015
QuadraSphere Microspheres
K153102 · Biosphere Medical, S.A.
KRD · Device, Vascular, For Promoting Embolization · 28d
Cleared Nov 21, 2015
PainKARE
K151034 · Triowave Technologies
NUH · Stimulator, Nerve, Transcutaneous, Over-the-counter · 218d
Cleared Nov 20, 2015
Collagen Dural Regeneration Matrix
K150825 · Collagen Matrix, Inc.
GXQ · Dura Substitute · 238d
Cleared Nov 20, 2015
BioArchitects Patient Specific Cranial/Craniofacial Plate
K151692 · Bioarchitects USA, LLC
GXN · Plate, Cranioplasty, Preformed, Non-alterable · 150d
Cleared Nov 16, 2015
ICS Impulse
K151504 · Gn Otometrics
GWN · Nystagmograph · 165d
Cleared Nov 16, 2015
Viradius Neurowire
K151825 · Mivi Neuroscience, Inc.
MOF · Guide, Wire, Catheter, Neurovasculature · 133d
Cleared Nov 12, 2015
Entropy Module, E-ENTROPY-01
K150298 · Ge Healthcare Filand OY
OLW · Index-generating Electroencephalograph Software · 279d
Cleared Nov 09, 2015
Patient Contoured Implant-PEEK (PCI-PEEK)
K151382 · KLS-Martin L.P.
GXN · Plate, Cranioplasty, Preformed, Non-alterable · 171d
Cleared Nov 05, 2015
Tyece OTC TENS Device
K150386 · Tyece , Ltd.
NUH · Stimulator, Nerve, Transcutaneous, Over-the-counter · 260d
Cleared Nov 05, 2015
IdentEvent
K150688 · Optima Neuroscience, Inc.
OMB · Automatic Event Detection Software For Full-montage Electroencephalograph · 233d
Cleared Oct 30, 2015
SYMBIS Surgical System
K143420 · Imris, Inc.
HAW · Neurological Stereotaxic Instrument · 336d
Cleared Oct 30, 2015
Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter
K150046 · Zoll Circulation, Inc.
NCX · System, Hypothermia, Intravenous, Cooling · 291d
Cleared Oct 30, 2015
X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System - Stat X8 (XS29)
K152040 · Advanced Brain Monitoring, Inc.
OMC · Reduced- Montage Standard Electroencephalograph · 100d
Cleared Oct 30, 2015
DURAFORM Dural Graft Implant
K152481 · Codman & Shurtleff, Inc.
GXQ · Dura Substitute · 60d
Cleared Oct 27, 2015
Codman Certas Plus Programmable Valve
K152152 · Medos International SARL
JXG · Shunt, Central Nervous System And Components · 85d
Cleared Oct 23, 2015
ICS CHARTR EP 200 WITH VEMP
K143670 · Gn Otometrics A/S
GWJ · Stimulator, Auditory, Evoked Response · 303d
Cleared Oct 23, 2015
R-40 EEG Amplifier
K151600 · Lifelines , Ltd.
GWL · Amplifier, Physiological Signal · 133d
Cleared Oct 21, 2015
ClearPoint System
K142505 · Mri Interventions, Inc.
HAW · Neurological Stereotaxic Instrument · 411d
Cleared Oct 20, 2015
Palm TENS
K150308 · Heat IN A Click, LLC
NUH · Stimulator, Nerve, Transcutaneous, Over-the-counter · 253d

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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