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
2301–2325 of 6334
Cleared Feb 17, 2012
GEODESIC EEG MOBILE 100 (GEM 100)
K112353 · Electrical Geodesics, Inc.
GWQ · Full-montage Standard Electroencephalograph · 185d
Cleared Feb 16, 2012
CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM
K113526 · Medos International SARL
JXG · Shunt, Central Nervous System And Components · 78d
Cleared Feb 15, 2012
ELECTROPULSE-COSMETIC
K113724 · Pain Relief Technologies
NFO · Stimulator, Transcutaneous Electrical, Aesthetic Purposes · 58d
Cleared Feb 02, 2012
CMAP PRO
K113074 · Medical Technologies, Inc.
IKN · Electromyograph, Diagnostic · 108d
Cleared Jan 27, 2012
ELECTRO-CAP SYSTEM
K112319 · Electro-Cap Intl., Inc.
GXY · Electrode, Cutaneous · 169d
Cleared Jan 27, 2012
SPOTLIGHT ACCESS SYSTEM
K113273 · Johnson & Johnson
GZT · Retractor, Self-retaining, For Neurosurgery · 81d
Cleared Jan 25, 2012
THERATRODE
K112312 · Phoenix Medical Devices, Llp
GXY · Electrode, Cutaneous · 167d
Cleared Jan 20, 2012
NEUROTECH RECOVERY
K112934 · Bio-Medical Research, Ltd.
GXY · Electrode, Cutaneous · 109d
Cleared Jan 09, 2012
NEUROTECH PLUS
K112258 · Bio-Medical Research, Ltd.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 157d
Cleared Jan 09, 2012
SYNTHECEL DURA REPLACEMENT DEVICES
K113071 · Synthes
GXQ · Dura Substitute · 84d
Cleared Jan 05, 2012
ELECTRO-GEL
K111717 · Electro-Cap Intl., Inc.
GYB · Media, Electroconductive · 199d
Cleared Jan 05, 2012
STRYKER UNIVERSAL NEURO 3 SYSTEM
K112557 · Stryker
GWO · Plate, Cranioplasty, Preformed, Alterable · 125d
Cleared Dec 21, 2011
GALAXY SYSTEM
K111055 · Personal Health Institute International
OLV · Standard Polysomnograph With Electroencephalograph · 250d
Cleared Dec 16, 2011
SBV2, MULTICHARGER MODEL MC10V2
K111514 · Sleep Performance D.B.A. Fatigue Science
LEL · Device, Sleep Assessment · 198d
Cleared Dec 16, 2011
SPOTLIGHT ACCESS SYSTEM
K112913 · Johnson & Johnson
GZT · Retractor, Self-retaining, For Neurosurgery · 74d
Cleared Dec 16, 2011
HYDROCOIL EMBOLIC SYSTEM (HES)
K113457 · MicroVention, Inc.
HCG · Device, Neurovascular Embolization · 24d
Cleared Dec 16, 2011
ANSPACH DISSECTION TOOLS
K113476 · The Anspach Effort, Inc.
HBE · Drills, Burrs, Trephines & Accessories (simple, Powered) · 24d
Cleared Dec 13, 2011
TARGET DETACHABLE COIL
K113412 · Stryker Neurovascular
HCG · Device, Neurovascular Embolization · 25d
Not Cleared Dec 13, 2011
INFRASCANNER, MODEL 1000
DEN100002 · Infrascan, Inc.
OPT · Infrared Hematoma Detector · 614d
Cleared Dec 09, 2011
THE BUZZ FACIAL TONING SYSTEM
K102494 · Daka International , Ltd.
NFO · Stimulator, Transcutaneous Electrical, Aesthetic Purposes · 465d
Cleared Dec 08, 2011
PRESSON ELECTRODE
K103103 · Persyst Development Corp.
GXZ · Electrode, Needle · 414d
Cleared Dec 08, 2011
MODEL PM3030
K110068 · Omron Healthcare, Inc.
NUH · Stimulator, Nerve, Transcutaneous, Over-the-counter · 332d
Cleared Dec 06, 2011
H-WAVE
K112485 · Electronic Waveform Lab, Inc.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 99d
Cleared Dec 01, 2011
HYDROCOIL(R) EMBOLIC SYSTEM (HES)
K112181 · MicroVention, Inc.
HCG · Device, Neurovascular Embolization · 126d
Cleared Dec 01, 2011
ASAHI CHIKAI 10 NEUROVASCULAR GUIDE WIRE
K112979 · Asahi Intecc Co., Ltd.
MOF · Guide, Wire, Catheter, Neurovasculature · 56d

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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