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
Cleared
Feb 15, 2018
AtriCure cryoICE cryo-ablation probe (CRYO2)
GXH
Device, Surgical, Cryogenic
29d
Cleared
Feb 01, 2018
Micromed BRAIN QUICK system
GWQ
Full-montage Standard Electroencephalograph
266d
Cleared
Jan 31, 2018
ODFS Pace XL
GZI
Stimulator, Neuromuscular, External Functional
265d
Cleared
Jan 31, 2018
Indego(R)
PHL
Powered Exoskeleton
77d
Cleared
Jan 26, 2018
SedLine Sedation Monitor
OLW
Index-generating Electroencephalograph Software
126d
Cleared
Jan 26, 2018
Embrace
POS
Physiological Signal Based Seizure Monitoring System
122d
Cleared
Jan 23, 2018
gammaCore-S
PKR
Non-invasive Vagus Nerve Stimulator - Headache
78d
Cleared
Jan 10, 2018
Electrodes with snap / Electrodes with pigtail
GXY
Electrode, Cutaneous
212d
Cleared
Jan 08, 2018
PreOp
OLX
Source Localization Software For Electroencephalograph Or Magnetoencephalograph
110d
Cleared
Jan 05, 2018
Electrodes with silver conductive
GXY
Electrode, Cutaneous
207d
Cleared
Nov 13, 2017
Stryker Universal Mesh
GWO
Plate, Cranioplasty, Preformed, Alterable
249d
Cleared
Nov 10, 2017
Aesculap Slim Clip Applier Forceps
HCI
Applier, Aneurysm Clip
29d
Cleared
Nov 08, 2017
CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit
GWM
Device, Monitoring, Intracranial Pressure
37d
Cleared
Oct 16, 2017
Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag
JXG
Shunt, Central Nervous System And Components
55d
Cleared
Oct 03, 2017
CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)
JXG
Shunt, Central Nervous System And Components
90d
Cleared
Sep 25, 2017
GALAXY G3 Mini Microcoil Delivery System
HCG
Device, Neurovascular Embolization
95d
Cleared
Aug 14, 2017
Artemis Neuro Evacuation Device
GWG
Endoscope, Neurological
98d
Cleared
Jul 19, 2017
POD Packing Coil
HCG
Device, Neurovascular Embolization
119d
Cleared
Jul 18, 2017
ES2 Neuromonitoring Accessory Instruments
PDQ
Neurosurgical Nerve Locator
29d
Cleared
Jul 14, 2017
MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch Resistant Microcoil Delivery System, DELTAFILL 18 Stretch Resistant Microcoil Delivery System, DELTAXSFT 10 Stretch Resistant Microcoil Delivery System, GALAXY G3 FILL and GALAXY G3 XSFT Stretch Resistant Microcoil Delivery System
HCG
Device, Neurovascular Embolization
31d
Cleared
Jul 01, 2017
ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tip
MOF
Guide, Wire, Catheter, Neurovasculature
30d
Cleared
May 25, 2017
MultiGen™ 2 RF Generator System
GXD
Generator, Lesion, Radiofrequency
119d
Cleared
May 19, 2017
Stryker Universal Neuro III System AXS Screw
HBW
Fastener, Plate, Cranioplasty
29d
Cleared
May 16, 2017
KARL STORZ ShuntScope
GWG
Endoscope, Neurological
90d
Cleared
May 05, 2017
Internal Distraction - Sterile
PBJ
Cranial Distraction System
163d
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