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
4751 Neurology devices
3626–3650 of 4751
Cleared Oct 02, 1997
SENSOR AMPLIFIER
K972515 · Pro-Tech Services, Inc.
GWL · Amplifier, Physiological Signal · 91d
Cleared Oct 02, 1997
BIO TROL
K972723 · Mindmedia Labs, Inc.
HCC · Device, Biofeedback · 73d
Cleared Sep 26, 1997
EMG RETRAINER
K972487 · Chattanooga Group, Inc.
HCC · Device, Biofeedback · 86d
Cleared Sep 22, 1997
ICS MEDICAL VEMR VIDEO EYE MOVEMENT RECORDER
K972631 · Ics Medical Corp.
GWN · Nystagmograph · 70d
Cleared Sep 16, 1997
STEALTHSTATION PASSIVE INSTRUMENT OPTION
K972398 · Surgical Navigation Technologies, Inc.
HAW · Neurological Stereotaxic Instrument · 82d
Cleared Sep 12, 1997
MIDAS REX MOTOR
K972289 · Midas Rex Pneumatic Tools, Inc.
HBB · Motor, Drill, Pneumatic · 85d
Cleared Sep 10, 1997
2D VOG - VIDEO-OCULOGRAPHY
K972243 · Sensomotoric Instruments, GmbH
GWN · Nystagmograph · 86d
Cleared Sep 04, 1997
AP-4000, AIR PULSE SENSORY STIMULATOR
K964815 · Pentax Precision Instrument Corp.
LLN · Device, Vibration Threshold Measurement · 279d
Cleared Aug 29, 1997
DREAM CATCHER
K972122 · Rest Technologies, Inc.
GXY · Electrode, Cutaneous · 85d
Cleared Aug 27, 1997
Z TECH TRANSCUTANEOUS NEURAL STIMULATION
K965244 · Z Technologies, LLC
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 246d
Cleared Aug 22, 1997
MEDTRONIC MODEL 3273/3274 RF RECEIVER AND MODEL 3629/3630 SCREENER
K972043 · Medtronic Vascular
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 81d
Cleared Aug 19, 1997
REGULUS NAVIGATOR
K964229 · Compass Intl., Inc.
HAW · Neurological Stereotaxic Instrument · 300d
Cleared Aug 18, 1997
EPIDURAL PEG ELECTRODE (EP), SPHENOIDAL ELECTRODE (EDS) AND FORAMEN, OVALE DEPTH ELECTRODE (ED-FO) FOR EPILEPSY MONITORI
K961942 · Radionics, Inc.
GYC · Electrode, Cortical · 455d
Cleared Aug 18, 1997
GUIDELINE SYSTEM
K970943 · Axon Instruments, Inc.
GZL · Electrode, Depth · 157d
Cleared Aug 15, 1997
E-READER
K970436 · Natural Herbal Products, Inc.
GZO · Device, Galvanic Skin Response Measurement · 191d
Cleared Aug 13, 1997
ALICE 4R SYSTEM
K971867 · Healthdyne Technologies, Inc.
OLV · Standard Polysomnograph With Electroencephalograph · 85d
Cleared Aug 06, 1997
MODEL HS-2 TENS DEVICE
K962951 · Technalithics Laboratories, Inc.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 376d
Cleared Aug 01, 1997
RELIEFBAND TENS UNIT (MODIFICATION)
K961050 · Maven Labs, Inc.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 540d
Cleared Aug 01, 1997
SPECTRUM II, SPECTRUM PLUS, AND SPECTRUM MAX-SD
K965187 · Sparta Surgical Corp.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 220d
Cleared Jul 31, 1997
ENDOSCOPIC VENTRICULAR CATHETER
K971617 · Integra Neurocare, LLC
JXG · Shunt, Central Nervous System And Components · 90d
Cleared Jul 29, 1997
WIRELESS EEG RECORDING SYSTEM MODEL W32
K963195 · Cme Telemetrix, Inc.
GYE · Encephalogram Telemetry System · 348d
Cleared Jul 28, 1997
MM-1 MOVEMENT MONITOR
K971318 · Axon Instruments, Inc.
GYD · Transducer, Tremor · 110d
Cleared Jul 24, 1997
RADIONICS CONTOUR FLEX VALVE, RADIONICS CONTOUR FLEX PLUS VALVE
K971511 · Radionics, Inc.
JXG · Shunt, Central Nervous System And Components · 87d
Cleared Jul 23, 1997
B SMART MODEL 1
K961817 · Koven Technology, Inc.
LEL · Device, Sleep Assessment · 439d
Cleared Jul 23, 1997
DEEG-LITE
K972202 · Grass-Telefactor Product Group
GWQ · Full-montage Standard Electroencephalograph · 42d

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All categories 4751 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