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
4713 Neurology devices
Cleared
May 08, 2017
Ceribell Pocket EEG Device
OMC
Reduced- Montage Standard Electroencephalograph
91d
Cleared
May 08, 2017
Adhesive Electrodes
GXY
Electrode, Cutaneous
59d
Cleared
May 05, 2017
Internal Distraction - Sterile
PBJ
Cranial Distraction System
163d
Cleared
May 02, 2017
Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit
GZB
Stimulator, Spinal-cord, Implanted (pain Relief)
105d
Cleared
May 01, 2017
MagVita TMS Therapy - w/MagPro R20
OBP
Transcranial Magnetic Stimulator
109d
Cleared
Apr 29, 2017
Digital TENS Unit
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
102d
Cleared
Apr 28, 2017
WAVi™ Headset and WAVi™ eSoc™ Single Use Electrode Contacts
GXY
Electrode, Cutaneous
238d
Cleared
Apr 28, 2017
BrainPulse 1100
POP
Cranial Motion Measurement Device
30d
Cleared
Apr 26, 2017
VisualEyes
GWN
Nystagmograph
168d
Cleared
Apr 25, 2017
MyoCycle Home, MyoCycle Pro
GZI
Stimulator, Neuromuscular, External Functional
98d
Cleared
Apr 21, 2017
StealthConnect Remote Viewing, Planning and Collaboration System
HAW
Neurological Stereotaxic Instrument
210d
Cleared
Apr 20, 2017
Penumbra 3D Revascularization Device
NRY
Catheter, Thrombus Retriever
185d
Cleared
Apr 17, 2017
Pressio 2 ICP Monitoring System
GWM
Device, Monitoring, Intracranial Pressure
262d
Cleared
Apr 14, 2017
Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
217d
Cleared
Apr 14, 2017
Complete Control System
GXY
Electrode, Cutaneous
179d
Not Cleared
Apr 14, 2017
gammaCore Non-invasive Vagus Nerve Stimulator
PKR
Non-invasive Vagus Nerve Stimulator - Headache
546d
Cleared
Apr 13, 2017
Coolief* Cooled RF Probe
GXI
Probe, Radiofrequency Lesion
125d
Cleared
Apr 12, 2017
Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes
GZL
Electrode, Depth
133d
Cleared
Apr 11, 2017
MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96
GXY
Electrode, Cutaneous
116d
Cleared
Apr 11, 2017
REMbrandt
OLZ
Automatic Event Detection Software For Polysomnograph With Electroencephalograph
110d
Cleared
Apr 05, 2017
Neurovision Nerve Locator Monitor (Nerveana), EMGView Software
GWF
Stimulator, Electrical, Evoked Response
30d
Cleared
Mar 31, 2017
StealthStation S8 System Platforms and StealthStation Cranial Software
HAW
Neurological Stereotaxic Instrument
226d
Cleared
Mar 31, 2017
EnsoSleep
OLZ
Automatic Event Detection Software For Polysomnograph With Electroencephalograph
192d
Cleared
Mar 31, 2017
MEP Monitor
GWF
Stimulator, Electrical, Evoked Response
169d
Cleared
Mar 29, 2017
V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System
HCG
Device, Neurovascular Embolization
152d
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