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
4744 Neurology devices
2926–2950 of 4744
Cleared Mar 28, 2005
NEUROPORT NEURAL SIGNAL PROCESSOR (NSP) SYSTEM
K042626 · Cyberkinetics, Inc.
GWQ · Full-montage Standard Electroencephalograph · 182d
Cleared Mar 24, 2005
CRYOMEDICAL INSTRUMENTS CRYO-PAC SYSTEMS
K050272 · Cryomedical Instruments, Ltd.
GXH · Device, Surgical, Cryogenic · 48d
Cleared Mar 18, 2005
ISIS MER SYSTEM/ELEKTA MER SYSTEM
K042208 · Inomed Medizintechnik GmbH
GZL · Electrode, Depth · 214d
Cleared Mar 17, 2005
COSMAN RF LESION GENERATOR, MODEL RFG-1A
K050084 · Cosman Medical, Inc.
GXI · Probe, Radiofrequency Lesion · 63d
Cleared Mar 16, 2005
ENFANTTM
K043491 · Diopsys, Inc.
GWE · Stimulator, Photic, Evoked Response · 89d
Cleared Mar 14, 2005
MODEL BMLS03-7
K042711 · Biomedical Life Systems, Inc.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 165d
Cleared Mar 09, 2005
TUNG FU AIRMATE TENS, VITALITY MODE, TF-DT001
K042107 · Tung FU Electric Co., Ltd.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 217d
Cleared Mar 04, 2005
DEPUY CAS KNEE INSTRUMENTATION
K043223 · DePuy Orthopaedics, Inc.
HAW · Neurological Stereotaxic Instrument · 102d
Cleared Mar 01, 2005
MPS (OR MPS-T)
K041838 · Innerspace, Inc.
GWM · Device, Monitoring, Intracranial Pressure · 237d
Cleared Feb 25, 2005
CONTACT HEAT-EVOKED POTENTIAL STIMULATOR (CHEPS)
K041908 · Medoc Ltd. Advanced Medical Systems
NTU · Evoked Potential Stimulator, Thermal · 225d
Cleared Feb 24, 2005
BIS SRS (SEMI-RESUABLE SENSOR)
K050313 · Aspect Medical Systems, Inc.
GWY · Pinwheel · 15d
Cleared Feb 11, 2005
INF 4160, MODEL D-FJ27F
K043407 · Fuji Dynamics Limited
LIH · Interferential Current Therapy · 63d
Cleared Feb 10, 2005
VECTORVISION OSTEOTOMY
K042513 · Brainlab AG
HAW · Neurological Stereotaxic Instrument · 148d
Cleared Feb 07, 2005
NAVIGUS NEXDRIVE, MODEL MI-3000
K043091 · Image-Guided Neurologics, Inc.
HAW · Neurological Stereotaxic Instrument · 90d
Cleared Feb 07, 2005
MEDTRONIC CLIP GUN KIT
K050044 · Medtronic Neurosurgery
HBO · Clip, Scalp · 28d
Cleared Feb 01, 2005
OMNIPRO SYSTEM
K050143 · Mays and Associates, Inc.
OLV · Standard Polysomnograph With Electroencephalograph · 11d
Cleared Jan 28, 2005
MEDTRONIC STRATAVARIUS
K041992 · Medtronic Neurosurgery
JXG · Shunt, Central Nervous System And Components · 189d
Cleared Jan 26, 2005
GEODESIC PHOTOGRAMMETRY SYSTEM
K043309 · Electrical Geodesics, Incorporated
GWQ · Full-montage Standard Electroencephalograph · 56d
Cleared Jan 25, 2005
ELEKTA NEUROMAG WITH MAXWELL FILTER
K050035 · Elekta Neuromag OY
OLX · Source Localization Software For Electroencephalograph Or Magnetoencephalograph · 18d
Cleared Jan 24, 2005
INTEGRITY, MODEL V500
K043396 · Vivosonic, Inc.
GWJ · Stimulator, Auditory, Evoked Response · 45d
Cleared Jan 21, 2005
CEREBRAL STATE MONITOR - CSM
K042315 · Danmeter A/S
OLW · Index-generating Electroencephalograph Software · 148d
Cleared Jan 14, 2005
NAVITRACK SYSTEM - S&N IMAGE FREE KNEE
K043536 · Orthosoft, Inc.
HAW · Neurological Stereotaxic Instrument · 23d
Cleared Jan 13, 2005
VECTORVISION ACL
K042512 · Brainlab AG
HAW · Neurological Stereotaxic Instrument · 120d
Cleared Jan 13, 2005
MEDICON VIPAIR HIGH SPEED SYSTEM
K042974 · Medicon EG
HBB · Motor, Drill, Pneumatic · 77d
Cleared Jan 12, 2005
BRAINET KIT
K043009 · Jordan Neuroscience, Inc.
GXY · Electrode, Cutaneous · 72d

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All categories 4744 HAW Neurological Stereotaxic Instrument 342 GXY Electrode, Cutaneous 307 GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief 279 JXG Shunt, Central Nervous System And Components 224 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