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
2876–2900 of 4737
Cleared Jul 11, 2005
MODIFICATION TO: NUVASIVE NEUROVISION JJB SYSTEM
K051384 · Nuvasive, Inc.
GWF · Stimulator, Electrical, Evoked Response · 45d
Cleared Jun 29, 2005
MODIFIED CONTACT-HEAT EVOKED POTENTIAL STIMULATOR (CHEPS)
K051448 · Medoc Ltd. Advanced Medical Systems
NTU · Evoked Potential Stimulator, Thermal · 27d
Cleared Jun 28, 2005
MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES)
K050954 · MicroVention, Inc.
HCG · Device, Neurovascular Embolization · 74d
Cleared Jun 28, 2005
NEXUS DETACHABLE COIL, MULTI-DIAMETER CSR AND HELIX SUPER SOFT CSR
K051560 · Micro Therapeutics, Inc.
HCG · Device, Neurovascular Embolization · 15d
Cleared Jun 27, 2005
FES CYCLE ERGOMETER, MODEL RT300-S
K050036 · Restorative Therapies, Inc.
GZI · Stimulator, Neuromuscular, External Functional · 171d
Cleared Jun 22, 2005
NEXUS DETACHABLE COIL SYSTEM, HELIX SUPER SOFT CSR
K051425 · Micro Therapeutics, Inc.
HCG · Device, Neurovascular Embolization · 21d
Cleared Jun 16, 2005
ENERGEX
K042686 · Energex Systems, Inc.
NHH · Device, Discharge, Electrostatic (for Pain Relief) · 260d
Cleared Jun 10, 2005
EKOS MICRO-INFUSION SYSTEM
K051225 · Ekos Corp.
NUI · Ultrasound, Infusion, System · 29d
Cleared Jun 08, 2005
STELTHSTATION WIRELESS SURGEON MOUSE
K051029 · Medtronic Surgical Navigation
HAW · Neurological Stereotaxic Instrument · 47d
Cleared Jun 02, 2005
STEALTHSTATION SYSTEM UPDATE
K050438 · Medtronic Surgical Navigation Technologies
HAW · Neurological Stereotaxic Instrument · 100d
Cleared Jun 01, 2005
MAYFIELD ACCISS II IMAGE GUIDED SURGERY SYSTEM, MODEL 2002-01
K041897 · Schaerer Mayfield USA, Inc.
HAW · Neurological Stereotaxic Instrument · 322d
Cleared Jun 01, 2005
ULTRA IVALON AND ULTRA DRIVALON PVA EMBOLIZATION PARTICLES
K042297 · Acta Vascular Systems, Inc.
HCG · Device, Neurovascular Embolization · 281d
Cleared May 31, 2005
STRYKER RF COAXIAL BIPOLAR ELECTRODES & CANNULAE
K043442 · Stryker Instruments
GXI · Probe, Radiofrequency Lesion · 168d
Cleared May 24, 2005
NAVIPRO SHOULDER SOFTWARE MODULE
K050897 · Kinamed, Inc.
HAW · Neurological Stereotaxic Instrument · 46d
Cleared May 23, 2005
DDAT OMT
K050098 · Ddat(Uk), Ltd.
GWN · Nystagmograph · 125d
Cleared May 18, 2005
ANS SCS ACCESSORY KIT
K050922 · Advanced Neuromodulation Systems
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 35d
Cleared May 17, 2005
IPLAN! DIGITAL TEMPLATING
K042543 · Brainlab AG
HAW · Neurological Stereotaxic Instrument · 239d
Cleared May 17, 2005
INTERX5000
K042912 · Neuro Resource Group, Inc.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 208d
Cleared May 17, 2005
NEUROSYSTEMS 1TM MONITOR
K050702 · Neurosystems, LLC
GWM · Device, Monitoring, Intracranial Pressure · 60d
Cleared May 17, 2005
MODIFICATION TO: VOYAGER LINUX
K050973 · Mako Surgical Corp.
HAW · Neurological Stereotaxic Instrument · 29d
Cleared May 13, 2005
EZ-STIK ELECTRODES
K050469 · Naimco, Inc.
GXY · Electrode, Cutaneous · 79d
Cleared May 13, 2005
EVERLIFE
K050788 · Everlife Medical Instrument Co., Ltd.
GXY · Electrode, Cutaneous · 46d
Cleared May 11, 2005
NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING KIT/SYSTEM, MODELS NS-P, NS-100
K050720 · Integra Neurosciences
GWM · Device, Monitoring, Intracranial Pressure · 51d
Cleared May 06, 2005
DATEX-OHMEDA S/5TM ENTROPY MODULE, E-ENTROPY AND ACCESSORIES
K050835 · Ge Healthcare
OLW · Index-generating Electroencephalograph Software · 35d
Cleared May 05, 2005
DISPOSABLE CONCENTRIC PROBE, DISPOSABLE BIPOLAR PROBE, DISPOSABLE MONOPOLAR PROBE
K050325 · Technomed Europe
GXZ · Electrode, Needle · 85d

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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