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
4730 Neurology devices
2651–2675 of 4730
Cleared Mar 22, 2007
PORTI 7 PHYSIOLOGICAL AMPLIFIER
K063599 · Tms International BV
GWL · Amplifier, Physiological Signal · 108d
Cleared Mar 21, 2007
QUADRA BLOC TENS, MODEL 101
K062547 · Gradient Technologies, LLC
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 203d
Cleared Mar 07, 2007
ULTRA LOW PROFILE RONGEUR
K062711 · Baxano, Inc.
HAE · Rongeur, Manual · 177d
Cleared Feb 28, 2007
CTLOGICS NAVIGATIONS SYSTEMS
K063408 · Praxim Medivision, SA
HAW · Neurological Stereotaxic Instrument · 107d
Cleared Feb 16, 2007
DISPOSABLE HYPODERMIC EMG NEEDLE ELECTRODE TECHNOMED EUROPE VERSION AND PRIVATE LABELED
K062437 · Technomed Europe
IKT · Electrode, Needle, Diagnostic Electromyograph · 189d
Cleared Feb 15, 2007
TOP NEUROPOLE NEEDLES, MODELS ST, X, RC, XE AND TL
K062946 · Top Corp.
GXI · Probe, Radiofrequency Lesion · 140d
Cleared Feb 15, 2007
QUATTRO CATHETER MODEL IC4593
K070161 · Alsius Corp.
NCX · System, Hypothermia, Intravenous, Cooling · 29d
Cleared Feb 13, 2007
BODIHEALTH SYSTEM
K052836 · Usa Laser Therapeutics, Inc.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 495d
Cleared Feb 09, 2007
ELECTROPULSE - LOW BACK PAIN
K062532 · Pain Relief Technologies
NUH · Stimulator, Nerve, Transcutaneous, Over-the-counter · 165d
Cleared Feb 07, 2007
OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2407
K063660 · Well-Life Healthcare Limited
NUH · Stimulator, Nerve, Transcutaneous, Over-the-counter · 61d
Cleared Feb 06, 2007
STAODYN MAX PRESET, MODEL 4470
K061516 · Compex Technologies, Inc.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 250d
Cleared Feb 05, 2007
ZIPPREP ELECTRODE
K070069 · Aspect Medical Systems, Inc.
GXY · Electrode, Cutaneous · 28d
Cleared Jan 26, 2007
ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM
K061297 · The Anspach Effort, Inc.
HBB · Motor, Drill, Pneumatic · 262d
Cleared Jan 25, 2007
GEODESIC EEG SYSTEM 300
K063797 · Electrical Geodesics, Incorporated
OLT · Non-normalizing Quantitative Electroencephalograph Software · 34d
Cleared Jan 24, 2007
MODIFICATION TO NUVASIVE NEUROVISION JJB SYSTEM
K062765 · Nuvasive, Inc.
GWF · Stimulator, Electrical, Evoked Response · 117d
Cleared Jan 24, 2007
MODIFICATION TO MERCI RETRIEVER, MODELS X5 AND X6
K063774 · Concentric Medical, Inc.
NRY · Catheter, Thrombus Retriever · 34d
Cleared Jan 22, 2007
SELECT TENS, MODEL 4600S
K061650 · Empi
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 223d
Cleared Jan 22, 2007
THERMOGARD THERMAL REGULATION SYSTEM
K063829 · Alsius Corp.
NCX · System, Hypothermia, Intravenous, Cooling · 27d
Cleared Jan 19, 2007
MODIFIED MERCI RETRIEVER, MODEL 90050
K062046 · Concentric Medical, Inc.
NRY · Catheter, Thrombus Retriever · 184d
Cleared Jan 17, 2007
AESCULAP-MEITHKE PROGAV PROGRAMMABLE VALVE, MODELS FV410T-FV451T
K062009 · Aesculap, Inc.
JXG · Shunt, Central Nervous System And Components · 184d
Cleared Jan 17, 2007
MODIFICATION TO VECTORVISION TRAUMA
K062358 · Brainlab AG
HAW · Neurological Stereotaxic Instrument · 156d
Cleared Jan 17, 2007
MICRUS MICROCOIL SYSTEM, CASHMERE MODEL SRC
K063653 · Micrus Endovascular Corporation
HCG · Device, Neurovascular Embolization · 40d
Cleared Jan 12, 2007
DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBES
K062996 · Axon Systems, Inc.
GXZ · Electrode, Needle · 102d
Cleared Jan 08, 2007
TRANSDISCAL SYSTEM, MODELS TDP-17-150-6, TDI-17-150, TDA-PPU-1, TDA-TBK-1, TDX-Y-TSW-TDP, TDX-PMG-PPU
K062937 · Baylis Medical Co., Inc.
GXI · Probe, Radiofrequency Lesion · 102d
Cleared Jan 08, 2007
REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM
K063405 · Radiant Medical
NCX · System, Hypothermia, Intravenous, Cooling · 60d

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All categories 4730 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