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
6334
Total
6279
Cleared
155d
Avg (2y)
1976
Since
6334 Neurology devices
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
Cleared
Mar 28, 2017
MR8 Drill System
HBC
Motor, Drill, Electric
99d
Cleared
Mar 27, 2017
Cleveland Multiport Ventricular Catheter Set
HCA
Catheter, Ventricular
277d
Cleared
Mar 24, 2017
MEDICON Spinal Spreading Systems
GZT
Retractor, Self-retaining, For Neurosurgery
280d
Cleared
Mar 24, 2017
iovera system
GXH
Device, Surgical, Cryogenic
262d
Cleared
Mar 23, 2017
Eclipse with VEMP
GWJ
Stimulator, Auditory, Evoked Response
244d
Cleared
Mar 23, 2017
Medtronic Legend Pneumatic
HBB
Motor, Drill, Pneumatic
129d
Cleared
Mar 23, 2017
Synapsys Ulmer Video Nystagmograph
GWN
Nystagmograph
94d
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