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
4748 Neurology devices
3276–3300 of 4748
Cleared Oct 18, 2000
NAVIGUS PEEL AWAY INTRODUCER
K002330 · Image-Guided Neurologics, Inc.
GWG · Endoscope, Neurological · 78d
Cleared Oct 13, 2000
MODIFICATION TO YASARGIL ANEURYSM CLIPS
K002871 · Aesculap, Inc.
HCH · Clip, Aneurysm · 29d
Cleared Oct 06, 2000
EEG SPIKE AND EVENT DETECTOR MODULE
K002332 · Excel Tech. , Ltd.
OMB · Automatic Event Detection Software For Full-montage Electroencephalograph · 66d
Cleared Oct 06, 2000
ADVANTAGE DRIVE SYSTEM
K002523 · Linvatec Corp.
HBC · Motor, Drill, Electric · 52d
Cleared Oct 02, 2000
STRYKER NAVIGATION SYSTEM - ENT MODULE
K002732 · Stryker Corp.
HAW · Neurological Stereotaxic Instrument · 31d
Cleared Sep 27, 2000
ASPECT MEDICAL SYSTEMS PEDIATRIC BIS EEG SENSOR, MODEL 186-0110
K001980 · Aspect Medical Systems, Inc.
GXY · Electrode, Cutaneous · 90d
Cleared Sep 21, 2000
SOPHY SU8 PRESSURE ADJUSTABLE VALVE
K992465 · Sophysa SA
JXG · Shunt, Central Nervous System And Components · 426d
Cleared Sep 19, 2000
BIS ENGINE
K002837 · Aspect Medical Systems, Inc.
OLW · Index-generating Electroencephalograph Software · 7d
Cleared Sep 14, 2000
BIO-LOGIC CEEGRAPH NETLINK
K002570 · Bio-Logic Systems Corp.
GWQ · Full-montage Standard Electroencephalograph · 27d
Cleared Sep 14, 2000
ASPECT MEDICAL SYTEMS EEG ENHANCED BIS SENSOR 186-0106
K002734 · Aspect Medical Systems, Inc.
GXY · Electrode, Cutaneous · 13d
Cleared Sep 12, 2000
MEDTRONIC PS MEDICAL POLYURETHANE SHUNT, MODELS 27521, 27116, 20022
K991502 · Medtronic PS Medical
JXG · Shunt, Central Nervous System And Components · 502d
Cleared Aug 31, 2000
128 CHANNEL EEG HEADBOX, MODEL EX-NW-128
K000919 · Excel Tech. , Ltd.
GWQ · Full-montage Standard Electroencephalograph · 162d
Cleared Aug 31, 2000
PARALLAX CRANIOSET
K994022 · Parallax Medical, Inc.
GXP · Methyl Methacrylate For Cranioplasty · 279d
Cleared Aug 17, 2000
ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE SYSTEM 2000 CABLE, ARTHROCARE SYSTEM 2000 FOOTSWITCH, ARTHROCARE SYSTEM 20
K001588 · Arthrocare Corp.
GXI · Probe, Radiofrequency Lesion · 86d
Cleared Aug 11, 2000
GDC ULTRASOFT COIL
K002181 · Boston Scientific, Target
HCG · Device, Neurovascular Embolization · 23d
Cleared Aug 04, 2000
MICROTARGETING ELECTRODE
K991522 · FHC, Inc.
GZL · Electrode, Depth · 459d
Cleared Aug 04, 2000
XDS EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM
K992226 · Radionics, Inc.
JXG · Shunt, Central Nervous System And Components · 399d
Cleared Aug 02, 2000
POLYMEDIC UPA NERVE STIMULATION NEEDLE
K990100 · Te ME NA S.A.R.L.
GXZ · Electrode, Needle · 576d
Cleared Aug 01, 2000
DA VINCHI EMG/EP ISA1004EP
K001467 · Airsep Corp.
GWE · Stimulator, Photic, Evoked Response · 83d
Cleared Jul 26, 2000
OPTICAL TRACKING SYSTEM (OTS)
K001950 · Radionics, Inc.
HAW · Neurological Stereotaxic Instrument · 29d
Cleared Jul 19, 2000
KSEA BIPOLAR COAGULATING ELECTRODES
K001630 · Karl Storz Endoscopy
GWG · Endoscope, Neurological · 54d
Cleared Jul 07, 2000
OPI BAND
K001167 · Orthomerica Products, Inc.
MVA · Orthosis, Cranial · 88d
Cleared Jul 06, 2000
MEDISANA DIGITAL TENS
K994265 · Fuji Dynamics Limited
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 202d
Cleared Jul 06, 2000
FDTENS 2010
K994266 · Fuji Dynamics Limited
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 202d
Cleared Jun 30, 2000
MODEL 4000 EEG MONITOR WITH PSI (PSA4000)
K001069 · Physiometrix, Inc.
OLW · Index-generating Electroencephalograph Software · 88d

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All categories 4748 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 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