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
2601–2625 of 6334
Cleared Dec 15, 2008
COMBOCARE 2000
K083202 · Xanacare Technologies, LLC
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 46d
Cleared Dec 09, 2008
RUGALIFT, MODEL# V.2.1
K071573 · Fatrotek S.R.L.
NFO · Stimulator, Transcutaneous Electrical, Aesthetic Purposes · 550d
Cleared Dec 08, 2008
MAGSTIM DOUBLE 70MM AIR FILM COIL, MODEL 3910-00
K080499 · The Magstim Company , Ltd.
GWF · Stimulator, Electrical, Evoked Response · 287d
Cleared Dec 05, 2008
STARBAND
K082950 · Orthomerica Products, Inc.
OAN · Orthosis, Cranial, Laser Scan · 63d
Cleared Nov 28, 2008
MEDISTIM XP, TYPE 281 AND MEDITENS XP, TYPE 458
K082011 · Bio-Medical Research, Ltd.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 136d
Cleared Nov 28, 2008
GE ENTROPY SENSOR
K082540 · Ge Healthcare
GXY · Electrode, Cutaneous · 87d
Cleared Nov 25, 2008
MAKO SURGICAL TACTILE GUIDANCE SYSTEM VERSION 2.0
K081867 · Mako Surgical Corp.
HAW · Neurological Stereotaxic Instrument · 147d
Cleared Nov 24, 2008
MODEL ES-130
K081943 · Ito Co., Ltd.
BWK · Stimulator, Electro-acupuncture · 139d
Cleared Nov 20, 2008
STRATA BURR HOLE VALVE, MODEL 42836 AND STRATA BURR HOLE SHUNT ASSEMBLY, MODEL 46836
K083076 · Medtronic Neurosurgery
JXG · Shunt, Central Nervous System And Components · 35d
Cleared Nov 10, 2008
TOP NEUROPOLE NEEDLE, MODEL SH, BL, SC, TC
K080771 · Top Corp.
GXI · Probe, Radiofrequency Lesion · 236d
Cleared Nov 06, 2008
OSV II
K081773 · Integra Neurosciences Implants S.A.
JXG · Shunt, Central Nervous System And Components · 136d
Cleared Nov 05, 2008
COMPONENT NEUROMONITORING SYSTEM
K080217 · Moberg Research, Inc.
OMA · Amplitude-integrated Electroencephalograph · 281d
Cleared Oct 31, 2008
NEUROLINK IP, MODEL PK1113
K081741 · Excel-Tech Ltd. (Xltek)
GWQ · Full-montage Standard Electroencephalograph · 134d
Cleared Oct 31, 2008
STARLIGHT
K082945 · Orthomerica Products, Inc.
OAN · Orthosis, Cranial, Laser Scan · 29d
Cleared Oct 29, 2008
PIGALILEO CAS, VERSION 4.0 AND TKR BASE, VERSION 2.1
K082267 · Smith & Nephew, Inc.
HAW · Neurological Stereotaxic Instrument · 79d
Cleared Oct 21, 2008
TENS/EMS COMBO, EMS, TENS
K082514 · Medihightec Medical Co., Ltd.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 49d
Cleared Oct 17, 2008
INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM
K080908 · Innercool Therapies, Inc.- A Delaware Corporation
NCX · System, Hypothermia, Intravenous, Cooling · 199d
Cleared Oct 17, 2008
ELECTRIC DRILL SYSTEM [XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONSOLE (IPC)]
K081475 · Medtronic Xomed, Inc.
HBE · Drills, Burrs, Trephines & Accessories (simple, Powered) · 143d
Cleared Oct 17, 2008
MICRUS MICROCOIL DELIVERY SYSTEM
K082739 · Micrus Endovascular Corporation
HCG · Device, Neurovascular Embolization · 29d
Cleared Oct 16, 2008
COSMAN G4 RADIOFREQUENCY GENERATOR, MODEL RFG-4
K082051 · Cosman Medical, Inc.
GXD · Generator, Lesion, Radiofrequency · 90d
Cleared Oct 14, 2008
COSMAN RF INJECTION ELECTRODES, MODELS CU, CUR, CCD, TCD, CP, CR, CN
K082012 · Cosman Medical, Inc.
GXI · Probe, Radiofrequency Lesion · 91d
Cleared Oct 10, 2008
AURAGEN CORTICAL SURFACE ELECTRODES
K082250 · Integra Neurosciences
GYC · Electrode, Cortical · 63d
Cleared Oct 08, 2008
MAYFIELD MR/X-RAY SKULL CLAMP
K081401 · Integra Lifesciences Corp.
HBL · Holder, Head, Neurosurgical (skull Clamp) · 142d
Not Cleared Oct 07, 2008
NEUROSTAR TMS SYSTEM
DEN070003 · Neuronetics
OBP · Transcranial Magnetic Stimulator · 502d
Cleared Oct 06, 2008
SEN-4100 ELECTRIC STIMULATOR
K071969 · Nihon Kohden America, Inc.
GWF · Stimulator, Electrical, Evoked Response · 447d

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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