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
4752 Neurology devices
3726–3750 of 4752
Cleared Jan 22, 1997
SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STERNOTOMY
K954717 · Sodem Diffusion SA
HBB · Motor, Drill, Pneumatic · 467d
Cleared Jan 17, 1997
MEDILOG VISION
K961636 · Oxford Instruments, Plc.
OLZ · Automatic Event Detection Software For Polysomnograph With Electroencephalograph · 263d
Cleared Jan 17, 1997
MEDILOG MPA-S
K961638 · Oxford Instruments Medical Systems
OLV · Standard Polysomnograph With Electroencephalograph · 263d
Cleared Jan 17, 1997
MEDILOG MR95
K961642 · Oxford Instruments, Plc.
GWQ · Full-montage Standard Electroencephalograph · 263d
Cleared Jan 13, 1997
FOUR-CHANNEL PREAMPLIFIER
K962455 · Cadwell Laboratories, Inc.
GWF · Stimulator, Electrical, Evoked Response · 202d
Cleared Jan 13, 1997
TWO-CHANNEL PREAMPLIFIER
K962457 · Cadwell Laboratories, Inc.
GWF · Stimulator, Electrical, Evoked Response · 202d
Cleared Jan 13, 1997
CADWELL FOUR-/EIGHT-CHANNEL PREAMPLIFIER
K962458 · Cadwell Laboratories, Inc.
GWF · Stimulator, Electrical, Evoked Response · 202d
Cleared Jan 10, 1997
OPTICAL DIGITIZER OPTION FOR VIEW POINT
K963221 · Philips Medical Systems (Cleveland), Inc.
HAW · Neurological Stereotaxic Instrument · 147d
Cleared Dec 24, 1996
CLARUS NEUROPEN ENDOSCOPIC PLACEMENT KIT MODEL 2125-XXX
K960915 · Clarus Medical Systems, Inc.
GWG · Endoscope, Neurological · 293d
Cleared Dec 20, 1996
CORDIS SHARP-ENDED STYLET
K955265 · Cordis Corp.
JXG · Shunt, Central Nervous System And Components · 402d
Cleared Dec 20, 1996
DISPOSABLE NEEDLE ELECTRODE
K961013 · Medelec Intl. Corp.
IKT · Electrode, Needle, Diagnostic Electromyograph · 282d
Cleared Dec 20, 1996
COMBINED INTRACRANIAL PRESSURE-TEMPERATURE SENSING SYSTEM (ICP/)
K962928 · Camino Neurocare, Inc.
GWM · Device, Monitoring, Intracranial Pressure · 144d
Cleared Dec 17, 1996
GDC PATIENT RETURN ELECTTRODE MODEL 45021
K963307 · Target Therapeutics
HCG · Device, Neurovascular Embolization · 117d
Cleared Dec 16, 1996
NOVUS STANDARD AND PEDIATRIC VALVES
K961859 · Integra Neurocare, LLC
JXG · Shunt, Central Nervous System And Components · 216d
Cleared Dec 16, 1996
EEG ELECTRODES
K962283 · Teca, Inc.
GXY · Electrode, Cutaneous · 186d
Cleared Dec 12, 1996
EQUINOX DIGITAL EEG SYSTEM
K962447 · Physiometrix, Inc.
GWQ · Full-montage Standard Electroencephalograph · 171d
Cleared Dec 12, 1996
GRASS MODEL 15 NEURODATA AMPLIFIER SYSTEM
K963669 · Astro-Med, Inc.
GWL · Amplifier, Physiological Signal · 90d
Cleared Dec 12, 1996
SHUNT TAP
K963802 · Integra Neurocare, LLC
JXG · Shunt, Central Nervous System And Components · 80d
Cleared Nov 29, 1996
OLYMPUS ULTRASONIC SURGICAL SYSTEM (USU)
K962952 · Olympus Optical, Co.
LBK · Neurosurgical Ultrasonic Instruments · 122d
Cleared Nov 25, 1996
MODEL 1310 NEUROLINK NEUROMONITORING SYSTEM
K962157 · Physiometrix, Inc.
GWQ · Full-montage Standard Electroencephalograph · 174d
Cleared Nov 21, 1996
RADIONICS SLUIJTER-MEHTA CANNULA
K963577 · Radionics, Inc.
GXD · Generator, Lesion, Radiofrequency · 76d
Cleared Nov 19, 1996
BIFURCATED Y-EXTENSION
K953742 · Medtronic Vascular
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 469d
Cleared Nov 19, 1996
ANSPAHC SPEED REDUCER
K960630 · The Anspach Effort, Inc.
HBB · Motor, Drill, Pneumatic · 284d
Cleared Nov 19, 1996
MIDAS REX III MOTOR
K962483 · Midas Rex Pneumatic Tools, Inc.
HBB · Motor, Drill, Pneumatic · 146d
Cleared Nov 15, 1996
M & R DISPOSABLE ELECTRODE (14200)
K963236 · M & R Mfg., Inc.
GXY · Electrode, Cutaneous · 88d

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All categories 4752 HAW Neurological Stereotaxic Instrument 342 GXY Electrode, Cutaneous 307 GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief 282 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