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
4726 Neurology devices
2451–2475 of 4726
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 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 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
Cleared Oct 02, 2008
BARE PLATINUM FRAMING COIL, MODEL(S) 100408BPFC-V,100412BPFC-V,100515BPFC-V100518BPFC-V,100522BPFC-V,100618BPFC-V100622B
K082461 · MicroVention, Inc.
HCG · Device, Neurovascular Embolization · 36d
Cleared Sep 29, 2008
UNIVERSAL ELECTRODES
K081871 · Neurometrix, Inc.
GXY · Electrode, Cutaneous · 90d
Cleared Sep 12, 2008
STARLIGHT
K081994 · Orthomerica Products, Inc.
OAN · Orthosis, Cranial, Laser Scan · 60d
Cleared Sep 12, 2008
TRUFILL DCS SYRINGE
K082324 · Cordis Neurovascular, Inc.
HCG · Device, Neurovascular Embolization · 29d
Cleared Sep 09, 2008
EA STIMULATOR
K080221 · Helio Medical Supplies, Inc.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 224d
Cleared Sep 08, 2008
COMPUMEDICS NEUVO
K081151 · Compumedics USA, Ltd.
GWQ · Full-montage Standard Electroencephalograph · 138d
Cleared Sep 05, 2008
BRAINLAB KNEE ESSENTIAL, BRAINLAB KNEE UNLIMITED CI KNEE, CI KNEE UNLIMITED
K073615 · Brainlab AG
HAW · Neurological Stereotaxic Instrument · 254d
Cleared Sep 04, 2008
NUTRITONE FACIAL BEAUTY SYSTEM
K070250 · Isomers Laboratories, Inc.
NFO · Stimulator, Transcutaneous Electrical, Aesthetic Purposes · 587d
Cleared Aug 29, 2008
NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200A
K080546 · Nihon Kohden America, Inc.
OLT · Non-normalizing Quantitative Electroencephalograph Software · 183d
Cleared Aug 29, 2008
COMBOCARE 2000
K081141 · Xanacare Technologies, LLC
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 129d
Cleared Aug 27, 2008
STRATA NSC BURR HOLE VALVE, MODEL 42335
K082127 · Medtronic Neurosurgery
JXG · Shunt, Central Nervous System And Components · 29d
Cleared Aug 15, 2008
MODIFICATION TO MERCI RETRIEVER
K082034 · Concentric Medical, Inc.
NRY · Catheter, Thrombus Retriever · 29d
Cleared Aug 13, 2008
MOFICATION TO: MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION
K082175 · Bioplate, Inc.
GXN · Plate, Cranioplasty, Preformed, Non-alterable · 12d
Cleared Aug 07, 2008
ARCTIC BLAST INTRAVENOUS FLUID CHILLER
K080899 · Medivance, Inc.
NCX · System, Hypothermia, Intravenous, Cooling · 129d
Cleared Aug 06, 2008
TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH PRAXITELES
K081232 · Praxim
HAW · Neurological Stereotaxic Instrument · 97d
Cleared Aug 05, 2008
DERMABIOSAFE
K080298 · Complete Product Resources
GXY · Electrode, Cutaneous · 182d
Cleared Aug 04, 2008
SELF-ADHESIVE ELECTRODES
K080276 · Cathay Health Care Equipment Manufacturing, Inc.
GXY · Electrode, Cutaneous · 182d
Cleared Jul 30, 2008
JOINT STIM, MODEL 1000
K073386 · Pain Management Technologies
NYN · Stimulator, Electrical, Transcutaneous, For Arthritis · 240d

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All categories 4726 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