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
6291
Total
6236
Cleared
153d
Avg (2y)
1976
Since
4737 Neurology devices
Cleared
Feb 09, 2006
IPLAN
HAW
Neurological Stereotaxic Instrument
94d
Cleared
Feb 07, 2006
XLTEK NEUROPATH, MODEL PK1070
JXE
Device, Nerve Conduction Velocity Measurement
99d
Cleared
Jan 30, 2006
MODIFIED PVA-PLUS FOAM EMBOLIZATION PARTICLES AND MAXISTAT AND MICROSTAT PVA FOAM EMBOLIZATION PARTICLES
HCG
Device, Neurovascular Embolization
41d
Cleared
Jan 25, 2006
FD TENS 2030, MODEL DFJ24T
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
113d
Cleared
Jan 24, 2006
BE PLUS / AURA-LTM64 AMPLIFIER
GWL
Amplifier, Physiological Signal
28d
Cleared
Jan 23, 2006
NT-1000
GXD
Generator, Lesion, Radiofrequency
103d
Cleared
Jan 19, 2006
PATHWAY - ATS/CHEPS
NTU
Evoked Potential Stimulator, Thermal
143d
Cleared
Jan 19, 2006
CODMAN HAKIM PROGRAMMABLE VALVE W/WO SIPHONGUARD
JXG
Shunt, Central Nervous System And Components
76d
Cleared
Jan 19, 2006
MODIFICATION TO CODMAN HAKIM SHUNT SYSTEMS
JXG
Shunt, Central Nervous System And Components
48d
Cleared
Jan 18, 2006
MICROSPEED UNI MOTOR SYSTEM
HBC
Motor, Drill, Electric
30d
Cleared
Jan 13, 2006
MSAS-VANTAGE
GZO
Device, Galvanic Skin Response Measurement
79d
Cleared
Jan 06, 2006
EKOS MICRO-INFUSION SYSTEM
NUI
Ultrasound, Infusion, System
28d
Cleared
Dec 28, 2005
ZIMMER COMPUTER ASSISTED SOLUTIONS-ELECTROMAGNETIC AND IMAGELESS KNEE INSTRUMENTATION
HAW
Neurological Stereotaxic Instrument
117d
Cleared
Dec 27, 2005
PROSTIM REUSABLE NEUROSTIMULATION ELECTRODES
GXY
Electrode, Cutaneous
76d
Cleared
Dec 21, 2005
MAGSTIM RAPID2, MAGSTIM SUPER RAPID2, MODELS 3004-000, 3005-00
GWF
Stimulator, Electrical, Evoked Response
166d
Cleared
Dec 20, 2005
THERAKNIT GARMENT ELECTRODE
GXY
Electrode, Cutaneous
33d
Cleared
Dec 16, 2005
MEDTRONIC M2 MAGNET ADJUSTMENT TOOL
JXG
Shunt, Central Nervous System And Components
107d
Cleared
Dec 16, 2005
IGI-SYSTEM
HAW
Neurological Stereotaxic Instrument
70d
Cleared
Dec 16, 2005
STRYKER CUSTOM TI IMPLANT
GXN
Plate, Cranioplasty, Preformed, Non-alterable
66d
Cleared
Dec 15, 2005
TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM LINE EXTENSION
HCG
Device, Neurovascular Embolization
29d
Cleared
Dec 15, 2005
ANS 90 CM AND 110 CM (3100 AND 3200 SERIES) LEAD KIT
GZB
Stimulator, Spinal-cord, Implanted (pain Relief)
24d
Cleared
Dec 14, 2005
SYNTHES PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANT
GXN
Plate, Cranioplasty, Preformed, Non-alterable
28d
Cleared
Dec 13, 2005
DEEPWAVE NEUROMODULATION PAIN THERAPY DEVICE
LIH
Interferential Current Therapy
112d
Cleared
Dec 09, 2005
CRONUS GUIDEWIRE, MODEL 001-001470-1
NDQ
System, Catheter Or Guidewire, Steerable (magnetic)
197d
Cleared
Dec 07, 2005
MICRUS MODIFIED MICROCOIL 18-SYSTEM, CERECYTE, MODEL CSP & CHE
HCG
Device, Neurovascular Embolization
23d
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