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
Nov 03, 2000
KSEA MINIATURE NEUROENDOSCOPE
GWG
Endoscope, Neurological
65d
Cleared
Oct 23, 2000
KSEA NEURO-FIBERSCOPE
GWG
Endoscope, Neurological
46d
Cleared
Oct 13, 2000
MODIFICATION TO YASARGIL ANEURYSM CLIPS
HCH
Clip, Aneurysm
29d
Cleared
Apr 28, 2000
MEDTRONIC MODEL 7499 EXTENSION
GZB
Stimulator, Spinal-cord, Implanted (pain Relief)
78d
Cleared
Apr 12, 2000
MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (38 CM), MODEL 3555-38
GZF
Stimulator, Peripheral Nerve, Implanted (pain Relief)
89d
Cleared
Apr 07, 2000
SIPHONGUARD CSF CONTROL DEVICE
JXG
Shunt, Central Nervous System And Components
284d
Cleared
Mar 13, 2000
CODMAN ETHISORB DURA PATCH
GXQ
Dura Substitute
325d
Cleared
Dec 15, 1999
DCI ENDOSCOPE
GWG
Endoscope, Neurological
57d
Cleared
Nov 18, 1999
CRANIOFACIAL CALCIUM PHOSPHATE CERAMIC BONE FILLER
GXP
Methyl Methacrylate For Cranioplasty
293d
Cleared
Jul 20, 1999
SYNTHES CRANIAL FLAP TWIST CLAMP
GXN
Plate, Cranioplasty, Preformed, Non-alterable
49d
Cleared
Jul 20, 1999
SYNTHES CRANIAL FLAP TUBE CLAMP
GXN
Plate, Cranioplasty, Preformed, Non-alterable
35d
Cleared
Jul 09, 1999
CODMAN MICROSENSOR VENTRICULAR CATHETER KIT
GWM
Device, Monitoring, Intracranial Pressure
88d
Cleared
Jun 24, 1999
SIEMENS INFINITY EEG POD
OLT
Non-normalizing Quantitative Electroencephalograph Software
90d
Cleared
Jun 03, 1999
KSEA NEURO-FIBERSCOPE
GWG
Endoscope, Neurological
64d
Cleared
Feb 12, 1999
AESCULAP AXIAL CLIP APPLIER
HCI
Applier, Aneurysm Clip
87d
Cleared
Feb 09, 1999
MEDTRONIC MODEL 7495 EXTENSION KIT
GZB
Stimulator, Spinal-cord, Implanted (pain Relief)
28d
Cleared
Dec 18, 1998
SUNDT SLIM-LINE ANEURYSM CLIP APPLIER
HCI
Applier, Aneurysm Clip
163d
Cleared
Dec 18, 1998
AESCULAP MINOP SYSTEM
GWG
Endoscope, Neurological
85d
Cleared
Dec 18, 1998
YASARGIL TITANIUM ANEURYSM CLIPS
HCH
Clip, Aneurysm
53d
Cleared
Nov 10, 1998
PERIPHERAL NERVE STIMULATION
GZF
Stimulator, Peripheral Nerve, Implanted (pain Relief)
88d
Cleared
Sep 02, 1998
AESCULAP HILAN MOTOR SYSTEM
HBB
Motor, Drill, Pneumatic
191d
Cleared
Jul 17, 1998
HAKIM MICRO PROGRAMMABLE VALVE SYSTEM
JXG
Shunt, Central Nervous System And Components
137d
Cleared
Jul 01, 1998
HAKIM PROGRAMMABLE VALVE SYSTEM
JXG
Shunt, Central Nervous System And Components
194d
Cleared
Mar 16, 1998
SYNTHES CRANIAL SPRING CLIP (CSC)
GWO
Plate, Cranioplasty, Preformed, Alterable
126d
Cleared
Feb 06, 1998
MEDTRONIC TWIST LOCK ANCHOR (PARTNUMBER 103953/3550TLA)
GZB
Stimulator, Spinal-cord, Implanted (pain Relief)
184d
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