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
4754 Neurology devices
3826–3850 of 4754
Cleared Mar 22, 1996
LEKSELL NEURO GENERATOR AND ACCESSORIES
K941823 · Elekta Instruments, Inc.
GXD · Generator, Lesion, Radiofrequency · 709d
Cleared Mar 22, 1996
ISOTRON III, ISOTRON IV
K955387 · Excel Tech. , Ltd.
LIH · Interferential Current Therapy · 121d
Cleared Mar 22, 1996
MULTI III, IV
K955860 · Excel Tech. , Ltd.
LIH · Interferential Current Therapy · 86d
Cleared Mar 20, 1996
EPIX XL TENS UNIT
K951903 · Empi
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 331d
Cleared Mar 14, 1996
DIGITAL CONDUCTANCE METER
K924313 · The Jayms Co.
HCC · Device, Biofeedback · 1296d
Cleared Mar 07, 1996
AESCULAP VENTRICULOSCOPE SYSTEM
K954394 · Aesculap, Inc.
GWG · Endoscope, Neurological · 171d
Cleared Mar 07, 1996
DISPOSABLE NEUROVIEW OPERATING SHEATH
K954938 · Neuro Navigational Corp.
GWG · Endoscope, Neurological · 129d
Cleared Mar 01, 1996
ELECTROENCEPHALOGRAPH (EEG)
K960170 · Moberg Medical, Inc.
GWF · Stimulator, Electrical, Evoked Response · 45d
Cleared Feb 29, 1996
CODMAN FIDUCIAL MARKER SYSTEM
K953568 · Codman & Shurtleff, Inc.
HAW · Neurological Stereotaxic Instrument · 213d
Cleared Feb 29, 1996
NEUROVIEW COAXIAL BIPOLAR ELECTRODE
K955351 · Neuro Navigational Corp.
GWG · Endoscope, Neurological · 100d
Cleared Feb 27, 1996
ORALSENSOR
K953257 · Cycura Corp.
HCC · Device, Biofeedback · 230d
Cleared Feb 09, 1996
MAYFIELD RADIOLUCENT 2000 SKULL CLAMP
K953124 · Ohio Medical Instrument Co., Inc.
HBL · Holder, Head, Neurosurgical (skull Clamp) · 219d
Cleared Feb 09, 1996
DIGITRACE HOME VIDEO SYSTEM
K955787 · New England Medical Instruments, Inc.
OMB · Automatic Event Detection Software For Full-montage Electroencephalograph · 50d
Cleared Feb 06, 1996
CLARUS SPINEPEN MODEL 2126
K955598 · Clarus Medical Systems, Inc.
GWG · Endoscope, Neurological · 60d
Cleared Feb 02, 1996
BRAINLAB STEROTATIC HEADRING
K952390 · Brainlab Med. Computersysteme GmbH
HAW · Neurological Stereotaxic Instrument · 256d
Cleared Feb 02, 1996
SS102 DUAL CHANNEL SEP STIMULATOR
K955257 · Axon Systems, Inc.
GWF · Stimulator, Electrical, Evoked Response · 87d
Cleared Jan 29, 1996
DISPOSABLE HYPODERMIC MONOPOLAR NEEDLE RECORDING ELECTRODE
K955335 · Chalgren Enterprises, Inc.
IKT · Electrode, Needle, Diagnostic Electromyograph · 70d
Cleared Jan 26, 1996
NEURONET
K952294 · Computational Diagnostics, Inc.
GWF · Stimulator, Electrical, Evoked Response · 255d
Cleared Jan 26, 1996
CONTOUR FLEX VALVES (REGULAR & SMALL)
K954285 · Radionics, Inc.
JXG · Shunt, Central Nervous System And Components · 134d
Cleared Jan 25, 1996
BITE BLOCK
K954352 · United States Endoscopy Group, Inc.
JXL · Block, Bite · 129d
Cleared Jan 25, 1996
CEEGRAPH TRAVELER AMBULATORY EEG RECORDER
K954954 · Bio-Logic Systems Corp.
GWQ · Full-montage Standard Electroencephalograph · 87d
Cleared Jan 24, 1996
STEALTHSTATION
K954276 · Surgical Navigation Technologies, Inc.
HAW · Neurological Stereotaxic Instrument · 133d
Cleared Jan 22, 1996
EMG DISC RECORDING ELECTRODE
K953354 · Chalgren Enterprises, Inc.
GXY · Electrode, Cutaneous · 189d
Cleared Jan 22, 1996
EMG RECORDING RING ELECTRODE
K953356 · Chalgren Enterprises, Inc.
GXY · Electrode, Cutaneous · 189d
Cleared Jan 22, 1996
EMG DISC RECORDING ELECTRODE
K953361 · Chalgren Enterprises, Inc.
GXY · Electrode, Cutaneous · 189d

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All categories 4754 HAW Neurological Stereotaxic Instrument 342 GXY Electrode, Cutaneous 307 GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief 284 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