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

6235
Total
6180
Cleared
154d
Avg (2y)
1976
Since
1739 Neurology devices
1076–1100 of 1739
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
Cleared Feb 14, 2020
Orion LifeSpan MEG
K191785 · Compumedics Limited
OLY · Magnetoencephalograph · 226d
Cleared Feb 13, 2020
ClearPoint System and Accessories
K200079 · Mri Interventions, Inc.
HAW · Neurological Stereotaxic Instrument · 30d
Cleared Feb 07, 2020
Vesta RF Cannula
K190259 · Biomerics
GXI · Probe, Radiofrequency Lesion · 365d
Cleared Feb 07, 2020
Elefix V Paste for EEG & EMG
K191975 · Nihon Kohden Corporation
GYB · Media, Electroconductive · 198d
Cleared Feb 07, 2020
Trevo NXT ProVue Retriever
K200117 · Stryker
POL · Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment · 17d
Cleared Feb 01, 2020
Optima Coil System
K200030 · Balt USA, LLC
HCG · Device, Neurovascular Embolization · 25d

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All categories 1739 NUH Stimulator, Nerve, Transcutaneous, Over-the-counter 121 HAW Neurological Stereotaxic Instrument 93 QJP Catheter, Percutaneous, Neurovasculature 91 GXY Electrode, Cutaneous 90 NRY Catheter, Thrombus Retriever 73 GZB Stimulator, Spinal-cord, Implanted (pain Relief) 71 JXG Shunt, Central Nervous System And Components 66 NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes 49 OBP Transcranial Magnetic Stimulator 48 HCG Device, Neurovascular Embolization 41 GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief 38 GWG Endoscope, Neurological 38 DQY Catheter, Percutaneous 36 MOF Guide, Wire, Catheter, Neurovasculature 29 GWQ Full-montage Standard Electroencephalograph 27