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
4747 Neurology devices
3201–3225 of 4747
Cleared Oct 29, 2001
APEX MEDICAL LCD TENS-VII
K012643 · Apex Medical Corp.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 77d
Cleared Oct 25, 2001
WINNER CM4 COMBINATION UNIT
K012848 · Rich-Mar Corp.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 63d
Cleared Oct 22, 2001
NAVIGUS II MR
K012719 · Image-Guided Neurologics, Inc.
HAW · Neurological Stereotaxic Instrument · 69d
Cleared Oct 15, 2001
EAR MUFFINS
K012384 · Bio-Logic Systems Corp.
HCC · Device, Biofeedback · 80d
Cleared Oct 05, 2001
COM-PATCH
K012140 · Apex Medical Corp.
GXY · Electrode, Cutaneous · 87d
Cleared Oct 01, 2001
CODMAN BACTISEAL CATHETERS
K003322 · Codman & Shurtleff, Inc.
HCA · Catheter, Ventricular · 342d
Cleared Oct 01, 2001
XLTEK LED GOGGLES, MODEL LED-01
K011794 · Excel Tech. , Ltd.
GWE · Stimulator, Photic, Evoked Response · 115d
Cleared Oct 01, 2001
NAVIGUS II TRAJECTORY GUIDE
K012366 · Image-Guided Neurologics, Inc.
HAW · Neurological Stereotaxic Instrument · 67d
Cleared Oct 01, 2001
BIS/EEG MODULE
K012466 · General Electric Medical Systems Information Techn
OLW · Index-generating Electroencephalograph Software · 61d
Cleared Sep 21, 2001
COLLAGEN NERVE CUFF
K012814 · Collagen Matrix, Inc.
JXI · Cuff, Nerve · 30d
Cleared Sep 12, 2001
VECTORVISION HIP
K010602 · Brainlab AG
HAW · Neurological Stereotaxic Instrument · 196d
Cleared Sep 06, 2001
VECTORVISION KNEE
K010612 · Brainlab AG
HAW · Neurological Stereotaxic Instrument · 189d
Cleared Sep 06, 2001
MODIFICATION TO: VECTORVISION FRAMELESS BIOPSY SYSTEM
K012564 · Brainlab AG
HAW · Neurological Stereotaxic Instrument · 28d
Cleared Aug 31, 2001
STRYKER NAVIGATION SYSTEM-KNEE MODULE
K010204 · Stryker Corp.
HAW · Neurological Stereotaxic Instrument · 220d
Cleared Aug 30, 2001
VECTORVISION CT/FLUORO
K010968 · Brainlab AG
HAW · Neurological Stereotaxic Instrument · 150d
Cleared Aug 08, 2001
ANSPACH EMAX DRILL SYSTEM
K011444 · The Anspach Effort, Inc.
HBC · Motor, Drill, Electric · 89d
Cleared Aug 03, 2001
NAVIGUS TRAJECTORY GUIDE BIOPSY KIT, MODELS BK-7000 AND 8000
K011971 · Image-Guided Neurologics, Inc.
HAW · Neurological Stereotaxic Instrument · 39d
Cleared Aug 02, 2001
SOMNO STAR & SERIES SLEEP SYSTEM
K012085 · Sensor Medics Corp.
OLV · Standard Polysomnograph With Electroencephalograph · 30d
Cleared Aug 01, 2001
MEDTRONIC MODEL 7495LZ LOW IMPEDANCE EXTENSION
K010300 · Medtronic Vascular
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 181d
Cleared Aug 01, 2001
MEDICON TITANIUM YASARGIL ANEURYSM CLIPS
K010908 · Medicon EG
HCH · Clip, Aneurysm · 128d
Cleared Aug 01, 2001
MEDICON YASARGIL CLIP APPLYING FORCEPS
K010910 · Medicon EG
HCI · Applier, Aneurysm Clip · 128d
Cleared Jul 10, 2001
BIS ENGINE
K011834 · Aspect Medical Systems, Inc.
OLW · Index-generating Electroencephalograph Software · 28d
Cleared Jul 03, 2001
STARBAND CRANIAL ORTHOSIS
K011350 · Orthomerica Products, Inc.
OAN · Orthosis, Cranial, Laser Scan · 62d
Cleared Jun 28, 2001
AESCULAP SPIEGELBERG BRAIN PRESSURE MONITOR
K003759 · Aesculap, Inc.
GWM · Device, Monitoring, Intracranial Pressure · 204d
Cleared Jun 28, 2001
NEUROPACK MICRO, MODEL MED-9100A SERIES
K010590 · Nihon Kohden America, Inc.
IKN · Electromyograph, Diagnostic · 121d

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All categories 4747 HAW Neurological Stereotaxic Instrument 342 GXY Electrode, Cutaneous 307 GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief 280 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 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