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
4704 Neurology devices
1126–1150 of 4704
Cleared Apr 24, 2020
GSI Audera Pro
K193033 · Grason Stadler
GWJ · Stimulator, Auditory, Evoked Response · 176d
Cleared Apr 23, 2020
Nurochek System
K200705 · Cryptych Pty, Ltd.
GWE · Stimulator, Photic, Evoked Response · 36d
Cleared Apr 21, 2020
Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP)
K200162 · Wuhan Greentek Pty , Ltd.
GXY · Electrode, Cutaneous · 90d
Cleared Apr 18, 2020
Route 92 Medical 088 Access System, 110 cm
K200121 · Route 92 Medical, Inc.
QJP · Catheter, Percutaneous, Neurovasculature · 88d
Cleared Apr 16, 2020
Traxcess 14 SELECT Guidewire
K200547 · MicroVention, Inc.
MOF · Guide, Wire, Catheter, Neurovasculature · 44d
Cleared Apr 09, 2020
Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags
K200630 · Medtronic, Inc.
GWM · Device, Monitoring, Intracranial Pressure · 30d
Cleared Apr 06, 2020
Neural Navigator
K191422 · Soterix Medical, Inc.
HAW · Neurological Stereotaxic Instrument · 313d
Cleared Apr 06, 2020
Q3 Distal Access Catheter, Q4 Distal Access Catheter, Q5 Distal Access Catheter, Q6Distal Access Catheter
K192558 · Mivi Neurovascular
DQY · Catheter, Percutaneous · 202d
Cleared Mar 31, 2020
iCEWav Neuromonitoring Platform
K191868 · Ice Neurosystems, Inc.
GWQ · Full-montage Standard Electroencephalograph · 263d
Cleared Mar 27, 2020
StimRouter Neuromodulation System
K200482 · Bioness, Inc.
GZF · Stimulator, Peripheral Nerve, Implanted (pain Relief) · 29d
Cleared Mar 26, 2020
gammaCore Sapphire
K191830 · Electrocore, Inc.
PKR · Non-invasive Vagus Nerve Stimulator - Headache · 261d
Cleared Mar 26, 2020
Becker External Drainage and Monitoring System
K200456 · Medtronic, Inc.
GWM · Device, Monitoring, Intracranial Pressure · 30d
Cleared Mar 23, 2020
Somryst
K191716 · Pear Therapeutics, Inc.
QVO · Computerized Behavioral Therapy Device For Insomnia · 271d
Cleared Mar 17, 2020
NeuralScan System
K192753 · Medeia, Inc.
GWQ · Full-montage Standard Electroencephalograph · 169d
Cleared Mar 14, 2020
Health Expert Electronic Stimulator (model: AST-300L)
K190783 · Shenzhen Osto Technology Company Limited
NUH · Stimulator, Nerve, Transcutaneous, Over-the-counter · 353d
Cleared Mar 13, 2020
NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate
K192162 · Neurovention, LLC
GXR · Cover, Burr Hole · 217d
Cleared Mar 04, 2020
TumEase Acupressure Bracelets
K193374 · Mumease
MVV · Device, Acupressure · 90d
Cleared Mar 04, 2020
L100 Go System
K200262 · Bioness, Inc.
GZI · Stimulator, Neuromuscular, External Functional · 30d
Cleared Feb 27, 2020
Penumbra System Penumbra JET 7X
K191946 · Penumbra, Inc.
NRY · Catheter, Thrombus Retriever · 220d
Cleared Feb 27, 2020
CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA Guide Sheath, 80cm, CEREBASE DA Guide Sheath, 70cm
K192804 · Medos International SARL
QJP · Catheter, Percutaneous, Neurovasculature · 149d
Cleared Feb 27, 2020
AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate Catheter
K200206 · Stryker Neurovascular
QJP · Catheter, Percutaneous, Neurovasculature · 30d
Cleared Feb 21, 2020
DORO LUCENT® iXI and iMRI Headrest System
K191740 · Pro-Med Instruments GmbH
HBL · Holder, Head, Neurosurgical (skull Clamp) · 235d
Cleared Feb 21, 2020
Coolief Radiofrequency Generator (CRG) System
K192491 · Avanos Medical, Inc.
GXD · Generator, Lesion, Radiofrequency · 163d
Cleared Feb 20, 2020
ApneaTrak
K192624 · Cadwell Industries, Inc.
OLV · Standard Polysomnograph With Electroencephalograph · 150d
Cleared Feb 14, 2020
Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)
K191346 · Blackrock Microsystems
GYC · Electrode, Cortical · 270d

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All categories 4704 HAW Neurological Stereotaxic Instrument 341 GXY Electrode, Cutaneous 302 GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief 275 JXG Shunt, Central Nervous System And Components 221 NUH Stimulator, Nerve, Transcutaneous, Over-the-counter 211 HCG Device, Neurovascular Embolization 173 GWQ Full-montage Standard Electroencephalograph 140 NRY Catheter, Thrombus Retriever 114 GZB Stimulator, Spinal-cord, Implanted (pain Relief) 113 GWF Stimulator, Electrical, Evoked Response 99 QJP Catheter, Percutaneous, Neurovasculature 97 GWG Endoscope, Neurological 86 NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes 74 GWM Device, Monitoring, Intracranial Pressure 71 OBP Transcranial Magnetic Stimulator 67