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
1755 Neurology devices
1326–1350 of 1755
Cleared Sep 07, 2018
GLOW800
K181537 · Leica Microsystems (Schweiz) AG
IZI · System, X-ray, Angiographic · 88d
Cleared Sep 06, 2018
Dual output digital therapy massager
K172834 · Shenzhen Osto Technology Co., Ltd.
NUH · Stimulator, Nerve, Transcutaneous, Over-the-counter · 352d
Cleared Sep 01, 2018
Cadwell Zenith System
K181466 · Cadwell Industries, Inc.
GWQ · Full-montage Standard Electroencephalograph · 89d
Cleared Aug 24, 2018
Solitaire 2 and Solitaire Platinum Revascularization Device
K181060 · Medtronic Neurovascular
POL · Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment · 123d
Cleared Aug 23, 2018
Freespira
K180173 · Palo Alto Health Sciences, Inc.
HCC · Device, Biofeedback · 213d
Cleared Aug 22, 2018
NIM PAK Needle
K180542 · Boston Endo Surgical Tech,
PDQ · Neurosurgical Nerve Locator · 174d
Cleared Aug 17, 2018
Optical Topography System ETG-4100
K172492 · Hitachi Healthcare Americas
DQA · Oximeter · 365d
Cleared Aug 17, 2018
Penumbra System Reperfusion Catheter JET 7
K173761 · Penumbra, Inc.
NRY · Catheter, Thrombus Retriever · 249d
Cleared Aug 17, 2018
BioWaveGO
K180943 · Biowave Corporation
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 129d
Not Cleared Aug 17, 2018
Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System
DEN170078 · Brainways , Ltd.
QCI · Transcranial Magnetic Stimulation System For Obsessive-compulsive Disorder · 322d
Cleared Aug 14, 2018
Mag Vita TMS Therapy System w/Theta Burst Stimulation
K173620 · Tonica Elektronik A/S
OBP · Transcranial Magnetic Stimulator · 265d
Cleared Aug 10, 2018
iStim S2 OTC Pain Relief TENS
K181849 · Everyway Medical Instruments Co., Ldt.
NUH · Stimulator, Nerve, Transcutaneous, Over-the-counter · 30d
Cleared Aug 09, 2018
Anchor Bolt (as an accessory to Depth Electrodes)
K181544 · Ad-Tech Medical Instrument Corporation
GZL · Electrode, Depth · 58d
Cleared Aug 08, 2018
EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay Access Catheter, 0.071 ID, 137cm Length, EagleRay Access Catheter, 0.055 ID, 137cm Length, EagleRay Access Catheter, 0.045 ID, 144cm Length, EagleRay Access Catheter, 0.035 ID, 158cm Length
K180169 · Imperative Care, Inc.
DQY · Catheter, Percutaneous · 198d
Cleared Aug 08, 2018
7D Surgical System Cranial Application
K181041 · 7D Surgical, Inc.
HAW · Neurological Stereotaxic Instrument · 111d
Cleared Aug 07, 2018
Self-adhesive Electrode
K181234 · Dong Guan OU Kang Electronics Co., Ltd.
GXY · Electrode, Cutaneous · 90d
Cleared Aug 07, 2018
Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profile, Volo 14 Guidewire, 300cm, Standard Profile
K181828 · Scientia Vascular, LLC
MOF · Guide, Wire, Catheter, Neurovasculature · 29d
Cleared Aug 03, 2018
HORIZON TMS Therapy System
K180907 · Magstim Company, Ltd.
OBP · Transcranial Magnetic Stimulator · 119d
Cleared Jul 31, 2018
SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer Kit
K181422 · Spr Therapeutics, Inc.
NHI · Stimulator, Nerve, Electrical, Percutaneous (pens), For Pain Relief · 61d
Cleared Jul 27, 2018
OsteoFab Patient Specific Cranial Device
K180064 · Oxford Performance Materials, Inc.
GXN · Plate, Cranioplasty, Preformed, Non-alterable · 199d
Cleared Jul 26, 2018
neuromate Gen III
K181706 · Renishaw Mayfield Sarl
HAW · Neurological Stereotaxic Instrument · 28d
Cleared Jul 24, 2018
I-Portal Neuro Otologic Test Center
K181025 · Neuro Kinetics, Inc.
GWN · Nystagmograph · 97d
Cleared Jul 23, 2018
Voyager Trajectory Array Guide (V-TAG)
K180854 · Voyager Therapeutics, Inc.
HAW · Neurological Stereotaxic Instrument · 112d
Cleared Jul 20, 2018
NicoletOne
K173366 · Natus Neurology Incorporated
OLZ · Automatic Event Detection Software For Polysomnograph With Electroencephalograph · 267d
Cleared Jul 20, 2018
GuardianTM Burr Hole Cover System
K181382 · St Jude Medical
GXR · Cover, Burr Hole · 56d

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All categories 1755 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 JXG Shunt, Central Nervous System And Components 73 GZB Stimulator, Spinal-cord, Implanted (pain Relief) 71 NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes 49 OBP Transcranial Magnetic Stimulator 48 HCG Device, Neurovascular Embolization 41 GWG Endoscope, Neurological 39 GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief 38 DQY Catheter, Percutaneous 36 MOF Guide, Wire, Catheter, Neurovasculature 29 GWQ Full-montage Standard Electroencephalograph 27