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
Apr 20, 2017
Penumbra 3D Revascularization Device
NRY
Catheter, Thrombus Retriever
185d
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 16, 2017
NuVasive Next Generation NVM5 System
PDQ
Neurosurgical Nerve Locator
210d
Cleared
Mar 16, 2017
TIPCAM 1S 3D System
GWG
Endoscope, Neurological
153d
Cleared
Feb 27, 2017
proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable Shunt System
JXG
Shunt, Central Nervous System And Components
236d
Cleared
Feb 22, 2017
Stryker Navigation System with CranialMap software application, Stryker CranialMap Planning software application, Stryker CranialMask Tracker
HAW
Neurological Stereotaxic Instrument
126d
Cleared
Sep 17, 2016
KARL STORZ Flexible Video-Neuro-Endoscope System
GWG
Endoscope, Neurological
150d
Cleared
Jul 22, 2016
ELAN 4 Motor System
HBC
Motor, Drill, Electric
289d
Cleared
Apr 02, 2015
AESCULAP - MEITHKE PROGAV 2.0 ADJUSTABLE SHUNT SYSTEM
JXG
Shunt, Central Nervous System And Components
294d
Cleared
Nov 14, 2014
MINOP Disposable Introducer 26F
GWG
Endoscope, Neurological
87d
Cleared
Sep 26, 2014
MEDLINE NEURO SPONGE
HBA
Neurosurgical Paddie
224d
Cleared
Jan 24, 2014
YASARGIL ANEURYSM CLIPS AND CLIP APPLIERS
HCH
Clip, Aneurysm
245d
Cleared
Jun 04, 2013
LYOPLANT ONLAY
GXQ
Dura Substitute
265d
Cleared
Sep 27, 2012
KARL STORZ NAVIGATIONPANEL UNIT (NPU) SYSTEM
HAW
Neurological Stereotaxic Instrument
73d
Cleared
Aug 30, 2012
CRAINFIX 2 TITANIUM CLAMP SYSTEM
GXN
Plate, Cranioplasty, Preformed, Non-alterable
27d
Cleared
May 24, 2012
AESCULAP-MEITHKE PROSA ADJUSTABLE SHUNT SYSTEM
JXG
Shunt, Central Nervous System And Components
90d
Cleared
Oct 27, 2011
AESCULAP- MEITHKE SHUNT SYSTEM
JXG
Shunt, Central Nervous System And Components
275d
Cleared
Feb 16, 2011
GDC 360 DETEACHABLE COIL
HCG
Device, Neurovascular Embolization
92d
Cleared
Dec 10, 2010
INZONE DETACHMENT SYSTEM
HCG
Device, Neurovascular Embolization
59d
Cleared
Nov 15, 2010
SCALP DURA RETRACTOR, MODEL KS00474
GZT
Retractor, Self-retaining, For Neurosurgery
411d
Cleared
Nov 09, 2010
AESCULAP- MEITHKE PROGAV PROGRAMMABLE SHUNT SYSTEM
JXG
Shunt, Central Nervous System And Components
28d
Cleared
Oct 26, 2010
MULTI-LEAD TRIALING CABLE MODEL 355531
GZB
Stimulator, Spinal-cord, Implanted (pain Relief)
54d
Cleared
Oct 15, 2010
TARGET DETACHABLE COIL
HCG
Device, Neurovascular Embolization
29d
Cleared
Aug 12, 2010
AESCULAP PEEK CRANIOFIX
GXR
Cover, Burr Hole
428d
Cleared
Apr 14, 2010
SYNTHES AIR PEN DRIVE (APD) SYSTEM
HBB
Motor, Drill, Pneumatic
168d
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