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
2826–2850 of 6334
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
Cleared Jan 04, 2007
GEMORE REUSEABLE SELF ADHESIVE ELECTRODE, MODELS WIRE SERIES, SNAP SERIES AND DOUBLE SIDE SERIES
K062675 · Gemore Technology Co, Ltd.
GXY · Electrode, Cutaneous · 118d
Cleared Jan 03, 2007
LIFECELL DURAL SUBSTITUTE MATRIX
K061208 · Lifecell Corp.
GXQ · Dura Substitute · 247d
Cleared Dec 22, 2006
BWII EEG DIGITAL, MODEL PV 1652
K062533 · Neurovirtual USA, Inc.
OLT · Non-normalizing Quantitative Electroencephalograph Software · 115d
Cleared Dec 22, 2006
SUBDERMAL WIRE ELECTRODE, MODEL SWE
K062880 · Ives Eeg Solutions, Inc.
GXZ · Electrode, Needle · 87d
Cleared Dec 22, 2006
O&P BIVALVE CRANIAL MOLDING HELMET
K063395 · Orthotic & Prosthetic Lab, Inc.
MVA · Orthosis, Cranial · 43d

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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