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
2626–2650 of 6334
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 25, 2008
L-ANEURYSM-CLIP SYSTEM & L-ANEURYSM CLIP APPLIERS, YASARGIL ANEURYSM CLIPS & YASARGIL ANEURYSM CLIP APPLIERS
K081489 · Peter Lazic GmbH
HCH · Clip, Aneurysm · 120d
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
SOLEX CATHETER, MODEL SL2593
K081936 · Alsius Corp.
NCX · System, Hypothermia, Intravenous, Cooling · 37d
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 12, 2008
NEUROCATH AG
K081942 · Vygon Neuro
JXG · Shunt, Central Nervous System And Components · 35d
Cleared Aug 08, 2008
INSTRUMED RONGEUR
K081651 · Instrumed International, Inc.
HAE · Rongeur, Manual · 57d
Cleared Aug 07, 2008
ARCTIC BLAST INTRAVENOUS FLUID CHILLER
K080899 · Medivance, Inc.
NCX · System, Hypothermia, Intravenous, Cooling · 129d
Cleared Aug 07, 2008
MODIFICATION TO GFX NERVE ABLATION SYSTEM
K081729 · Bioform Medical, Inc.
GXD · Generator, Lesion, Radiofrequency · 50d
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
Cleared Jul 28, 2008
ELEKTA NEUROMAG WITH MAXWELL FILTER WITH INTERNAL ACTIVE SHIELDING
K081430 · Elekta Neuromag OY
OLX · Source Localization Software For Electroencephalograph Or Magnetoencephalograph · 68d
Cleared Jul 18, 2008
PIGALILEO 4TH GENERATION SYSTEM
K080875 · Smith & Nephew, Inc.
HAW · Neurological Stereotaxic Instrument · 109d

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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