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
6334
Total
6279
Cleared
155d
Avg (2y)
1976
Since
6334 Neurology devices
Cleared
Jul 14, 2010
DISPOSABLE REFLECTIVE MARKER SPHERES
HAW
Neurological Stereotaxic Instrument
188d
Cleared
Jul 09, 2010
NIHON KOHDEN QP-160AK EEG TREND PROGRAM
OMA
Amplitude-integrated Electroencephalograph
323d
Cleared
Jul 01, 2010
EARPROBE
GWJ
Stimulator, Auditory, Evoked Response
115d
Cleared
Jun 29, 2010
WAVESTATE NEUROMONITOR
ORT
Burst Suppression Detection Software For Electroencephalograph
306d
Cleared
Jun 25, 2010
4 CHANNELS MULTIPLE MODEL DIGITAL ELECTRICAL STIMULATOR, MODEL NUVOSTIM IV, WL-2504A
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
129d
Cleared
Jun 25, 2010
MYOSCIENCE CRYO-TOUCH
GXH
Device, Surgical, Cryogenic
128d
Cleared
Jun 16, 2010
OLYMPIC BRAINZ MONITOR MODEL OBM70001
OMA
Amplitude-integrated Electroencephalograph
175d
Cleared
Jun 14, 2010
MINTA RYAN RF THERMOCOUPLE ELECTRODE (RYAN-50, 100, 150 AND 200), MINTA INTERMEDIATE CABLE (RYAN-C, -R, -B)
GXI
Probe, Radiofrequency Lesion
465d
Cleared
Jun 14, 2010
SUDOSCAN
GZO
Device, Galvanic Skin Response Measurement
139d
Cleared
May 28, 2010
SCENAR, MODEL 10
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
318d
Cleared
May 26, 2010
TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM
HCG
Device, Neurovascular Embolization
153d
Cleared
May 21, 2010
PENUMBRA SYSTEM SEPARATOR FLEX (026,032,041,054), MODELS PSF026, PSF032, PSF041, PSF054
NRY
Catheter, Thrombus Retriever
64d
Cleared
May 14, 2010
MODIFCATION TO: NUVASIVE NEUROVISION EMG ENDOTRACHEAL TUBE
GWF
Stimulator, Electrical, Evoked Response
134d
Cleared
May 06, 2010
VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITED
HAW
Neurological Stereotaxic Instrument
267d
Cleared
Apr 29, 2010
BE MICRO, TREA
OLV
Standard Polysomnograph With Electroencephalograph
147d
Cleared
Apr 22, 2010
HYDROCOIL EMBOLIC SYSTEM-HYDROFRAME MODEL 100931HFM-V, 101243HFM-V, 180827HFM-V, 181139HFM-V, 181445HFM-V, 181850HFM-V
HCG
Device, Neurovascular Embolization
64d
Cleared
Apr 16, 2010
LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES
HCG
Device, Neurovascular Embolization
108d
Cleared
Apr 15, 2010
LASERTOUCHONE (OTC)
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
90d
Cleared
Apr 14, 2010
SYNTHES AIR PEN DRIVE (APD) SYSTEM
HBB
Motor, Drill, Pneumatic
168d
Cleared
Apr 09, 2010
NEUROLINK IP MODEL: PK1117
GWQ
Full-montage Standard Electroencephalograph
30d
Cleared
Apr 02, 2010
ELECTRO-ACUPUNCTURE: ACULIFE/MODEL IDOC-01
BWK
Stimulator, Electro-acupuncture
276d
Cleared
Mar 31, 2010
IMNS MEDACTA NAVIGATION SYSTEM,33.221000US
HAW
Neurological Stereotaxic Instrument
55d
Cleared
Mar 30, 2010
HIVOX ELECTRIC STIMULATOR TENS & EMS, HD2
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
232d
Cleared
Mar 26, 2010
MAGPRO, MODELS R30 WITH MAGOPTION, X100, X100 WITH MAGOPTION
GWF
Stimulator, Electrical, Evoked Response
269d
Cleared
Mar 18, 2010
NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800
GWL
Amplifier, Physiological Signal
197d
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