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
4749 Neurology devices
3326–3350 of 4749
Cleared Mar 13, 2000
MACHIDA FLEXIBLE NEURO-ENDOSCOPE, MODELS NEU-4, NEU-4L
K993568 · Machida Endoscope Co., Ltd.
GWG · Endoscope, Neurological · 144d
Cleared Mar 06, 2000
GRASS TS3201/6401 EEG AMPLIFIER SYSTEM
K994142 · Grass Instrument Co.
OLV · Standard Polysomnograph With Electroencephalograph · 89d
Cleared Mar 01, 2000
MEDAMICUS EPIDURAL INTRODUCER
K994097 · Medamicus, Inc.
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 89d
Cleared Feb 23, 2000
SNN STEREOTAXIC PLANNING APPLICATION
K994421 · Surgical Navigation Specialists, Inc.
HAW · Neurological Stereotaxic Instrument · 56d
Cleared Feb 22, 2000
STEALTHSTATION TREATMENT GUIDANCE PLATFORM
K992461 · Surgical Navigation Technologies, Inc.
HAW · Neurological Stereotaxic Instrument · 214d
Cleared Feb 22, 2000
LEIBINGER QUIK DISK TITANIUM CLAMP SYSTEM
K993990 · Stryker Instruments
GXN · Plate, Cranioplasty, Preformed, Non-alterable · 90d
Cleared Feb 15, 2000
VOYAGER 6.0 SOFTWARE OPTION
K000310 · Philips Medical Systems (Cleveland), Inc.
HAW · Neurological Stereotaxic Instrument · 14d
Cleared Feb 11, 2000
TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR SE-30 TENS
K991397 · Sein Electronics Co., Ltd.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 296d
Cleared Feb 08, 2000
SPETZLER ROUND HANDLE APPLIERS, MODELS C-3753, C-3753T, C-3754, C-3754T
K994191 · Nmt Medical, Inc.
HCI · Applier, Aneurysm Clip · 57d
Cleared Feb 03, 2000
SD-730 IF-SDS, PERFECT PULSE IF-SDS
K992652 · Skylark Device & Systems Co., Ltd.
LIH · Interferential Current Therapy · 181d
Cleared Feb 01, 2000
JE 2000
K993878 · Jack'S Electrodes
IKN · Electromyograph, Diagnostic · 78d
Cleared Jan 27, 2000
NEUROCOMP
K993654 · Neurocybernetics
HCC · Device, Biofeedback · 90d
Cleared Jan 24, 2000
NEUROTREK PHYSIOLOGICAL NAVIGATION SYSTEM FOR NEUROSURGERY
K993622 · Alpha Omega , Ltd.
GZL · Electrode, Depth · 90d
Cleared Jan 21, 2000
GDC-10 STRETCH RESISTANT GUGLIELMI DETACHABLE COIL, GDC-10 2-DIAMETER STRETCH RESISTANT GUGLIELMI DETACHABLE COIL, GDC-1
K993415 · Boston Scientific, Target
HCG · Device, Neurovascular Embolization · 112d
Cleared Jan 21, 2000
GDC-10 GUGLIELMI DETACHABLE COIL (GDC) (3D SHAPE GDC), GDC-18 GUGLIELMI DETACHABLE COIL (GDC) (3D SHAPE GDC)
K993417 · Boston Scientific, Target
HCG · Device, Neurovascular Embolization · 112d
Cleared Jan 21, 2000
FIBERED GDC-18 VORTX SHAPE GUGLIELMI DETACHABLE COIL
K993418 · Boston Scientific, Target
HCG · Device, Neurovascular Embolization · 112d
Cleared Jan 20, 2000
MSAS PROFESSIONAL
K993824 · Biomeridian, Int.
GZO · Device, Galvanic Skin Response Measurement · 69d
Cleared Jan 18, 2000
STRYKER NAVIGATION SYSTEM - NEURO MODULE, MODEL 6000-XXX-XXX
K993239 · Stryker Corp.
HAW · Neurological Stereotaxic Instrument · 113d
Cleared Jan 18, 2000
ASPECT MEDICAL SYSTEMS EEG SENSOR, MODEL 186-0076
K994330 · Aspect Medical Systems, Inc.
GXY · Electrode, Cutaneous · 26d
Cleared Jan 11, 2000
BRAINLAB STEREOTACTIC ARC
K992916 · Brainlab
HAW · Neurological Stereotaxic Instrument · 134d
Cleared Jan 07, 2000
MAGSTIM RAPID
K992911 · Magstim Corporation US
GWF · Stimulator, Electrical, Evoked Response · 130d
Cleared Jan 06, 2000
PSI TITANIUM ANEURYSM CLIP
K991959 · V. Mueller Neuro/Spine
HCH · Clip, Aneurysm · 210d
Cleared Dec 29, 1999
STEALTHSTATION TREATMENT GUIDANCE PLATFORM
K992927 · Surgical Navigation Technologies, Inc.
HAW · Neurological Stereotaxic Instrument · 120d
Cleared Dec 27, 1999
SODEM PERFORATOR DRIVE
K993851 · Sodemsystems
HBB · Motor, Drill, Pneumatic · 45d
Cleared Dec 27, 1999
MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL FOR ABAER/ NAVIGATOR PRO.
K994149 · Bio-Logic Systems Corp.
GWJ · Stimulator, Auditory, Evoked Response · 19d

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All categories 4749 HAW Neurological Stereotaxic Instrument 342 GXY Electrode, Cutaneous 307 GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief 281 JXG Shunt, Central Nervous System And Components 224 NUH Stimulator, Nerve, Transcutaneous, Over-the-counter 211 HCG Device, Neurovascular Embolization 173 GWQ Full-montage Standard Electroencephalograph 142 NRY Catheter, Thrombus Retriever 114 GZB Stimulator, Spinal-cord, Implanted (pain Relief) 113 GWF Stimulator, Electrical, Evoked Response 101 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