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
4706 Neurology devices
Cleared
Sep 26, 2018
Everyway Wireless TENS & EMS Unit
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
90d
Cleared
Sep 19, 2018
Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit
GZB
Stimulator, Spinal-cord, Implanted (pain Relief)
159d
Cleared
Sep 15, 2018
ThermaCare Quick Therapy TENS
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
142d
Cleared
Sep 14, 2018
Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)
GXI
Probe, Radiofrequency Lesion
214d
Cleared
Sep 13, 2018
TENS device-HeadaTerm, eEspress
PCC
Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
395d
Cleared
Sep 13, 2018
SelectFlex 072 Neurovascular Access System
DQY
Catheter, Percutaneous
150d
Cleared
Sep 07, 2018
GLOW800
IZI
System, X-ray, Angiographic
88d
Cleared
Sep 06, 2018
Dual output digital therapy massager
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
352d
Cleared
Sep 01, 2018
Cadwell Zenith System
GWQ
Full-montage Standard Electroencephalograph
89d
Cleared
Aug 24, 2018
Solitaire 2 and Solitaire Platinum Revascularization Device
POL
Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
123d
Cleared
Aug 23, 2018
Freespira
HCC
Device, Biofeedback
213d
Cleared
Aug 22, 2018
NIM PAK Needle
PDQ
Neurosurgical Nerve Locator
174d
Cleared
Aug 17, 2018
Optical Topography System ETG-4100
DQA
Oximeter
365d
Cleared
Aug 17, 2018
Penumbra System Reperfusion Catheter JET 7
NRY
Catheter, Thrombus Retriever
249d
Cleared
Aug 17, 2018
BioWaveGO
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
129d
Not Cleared
Aug 17, 2018
Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System
QCI
Transcranial Magnetic Stimulation System For Obsessive-compulsive Disorder
322d
Cleared
Aug 14, 2018
Mag Vita TMS Therapy System w/Theta Burst Stimulation
OBP
Transcranial Magnetic Stimulator
265d
Cleared
Aug 10, 2018
iStim S2 OTC Pain Relief TENS
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
30d
Cleared
Aug 09, 2018
Anchor Bolt (as an accessory to Depth Electrodes)
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
DQY
Catheter, Percutaneous
198d
Cleared
Aug 08, 2018
7D Surgical System Cranial Application
HAW
Neurological Stereotaxic Instrument
111d
Cleared
Aug 07, 2018
Self-adhesive Electrode
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
MOF
Guide, Wire, Catheter, Neurovasculature
29d
Cleared
Aug 03, 2018
HORIZON TMS Therapy System
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
NHI
Stimulator, Nerve, Electrical, Percutaneous (pens), For Pain Relief
61d
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