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
1750 Neurology devices
Cleared
Apr 11, 2019
Codman Electrosurgical Generator, Foot Pedal
GEI
Electrosurgical, Cutting & Coagulation & Accessories
113d
Cleared
Apr 10, 2019
NAV PAK Needle, NIM NAV PAK Needle
PDQ
Neurosurgical Nerve Locator
197d
Cleared
Apr 04, 2019
Dome Electrode
GXY
Electrode, Cutaneous
42d
Cleared
Apr 03, 2019
DAEHAN Disposable CUP Electrodes
GXY
Electrode, Cutaneous
429d
Cleared
Apr 03, 2019
HORIZON TMS Therapy System with Navigation
OBP
Transcranial Magnetic Stimulator
118d
Cleared
Mar 29, 2019
Freedom Spinal Cord Stimulator (SCS) System
GZB
Stimulator, Spinal-cord, Implanted (pain Relief)
182d
Cleared
Mar 29, 2019
Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 cm: Single 8/Dual 8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 cm Kit, 40 cm/ 60 cm Trial/Extension Lead Kits, Patient Kits and miscellaneous replacement kits
GZF
Stimulator, Peripheral Nerve, Implanted (pain Relief)
98d
Not Cleared
Mar 28, 2019
Leica FL400
QFX
Diagnostic Neurosurgical Microscope Filter
335d
Cleared
Mar 26, 2019
SM Electrodes
GXY
Electrode, Cutaneous
132d
Cleared
Mar 22, 2019
Nexstim Navigated Brain Therapy (NBT) System 2
OBP
Transcranial Magnetic Stimulator
176d
Cleared
Mar 22, 2019
Nalu Neurostimulation System
GZB
Stimulator, Spinal-cord, Implanted (pain Relief)
140d
Cleared
Mar 22, 2019
Aristotle 18 Guidewire, 200cm, Soft Profile
MOF
Guide, Wire, Catheter, Neurovasculature
86d
Cleared
Mar 21, 2019
Ballast 088 Long Sheath
DQY
Catheter, Percutaneous
153d
Cleared
Mar 21, 2019
Route 92 Medical Delivery Catheter
DQY
Catheter, Percutaneous
27d
Cleared
Mar 19, 2019
AE-120A EEG Head Set
OMC
Reduced- Montage Standard Electroencephalograph
90d
Cleared
Mar 15, 2019
HORIZON TMS Therapy System
OBP
Transcranial Magnetic Stimulator
156d
Cleared
Mar 15, 2019
HIVOX OTC Electrical Stimulator
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
29d
Cleared
Mar 14, 2019
JKH Stimulator Plus
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
211d
Cleared
Mar 14, 2019
L300 Go System
GZI
Stimulator, Neuromuscular, External Functional
31d
Cleared
Mar 13, 2019
AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access Catheter 068 x 125cm, AXS Catalyst Distal Access Catheter 068 x 132cm
DQY
Catheter, Percutaneous
89d
Cleared
Mar 13, 2019
AXS Catalyst 7 Distal Access Catheter (068 x 115cm, 068 x 125cm, 068 x 132cm)
NRY
Catheter, Thrombus Retriever
89d
Cleared
Mar 12, 2019
AirRay Subdural Cortical Electrodes
GYC
Electrode, Cortical
90d
Cleared
Mar 08, 2019
Nitinol Thermocouple (TCN) Electrode
GXI
Probe, Radiofrequency Lesion
112d
Cleared
Mar 08, 2019
Brainsway Deep TMS System
QCI
Transcranial Magnetic Stimulation System For Obsessive-compulsive Disorder
101d
Cleared
Mar 08, 2019
Rulo Radiofrequency Lesion Probe
GXI
Probe, Radiofrequency Lesion
29d
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