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
4724 Neurology devices
Cleared
Jan 26, 2011
CERSR ELECTROMYOGRAPHY SYSTEM
IKN
Electromyograph, Diagnostic
20d
Cleared
Jan 14, 2011
CODMAN BACTISEAL CATHETERS, CODMAN BACTISEAL EVD CATHETER
JXG
Shunt, Central Nervous System And Components
127d
Cleared
Dec 20, 2010
CAMINO 110-4B OLM INTRACRANIAL PRESSURE MNITORING KIT
GWM
Device, Monitoring, Intracranial Pressure
80d
Cleared
Dec 10, 2010
INZONE DETACHMENT SYSTEM
HCG
Device, Neurovascular Embolization
59d
Cleared
Dec 03, 2010
MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079
HBW
Fastener, Plate, Cranioplasty
155d
Cleared
Nov 24, 2010
MAX-IF1000
LIH
Interferential Current Therapy
301d
Cleared
Nov 23, 2010
INTEGRA ELECTRODE TUNNELING NEEDLE
GYC
Electrode, Cortical
57d
Cleared
Nov 18, 2010
MICROPLEX COIL SYSTEM- COSMOS
KRD
Device, Vascular, For Promoting Embolization
90d
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
Sep 23, 2010
NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY
GXP
Methyl Methacrylate For Cranioplasty
66d
Cleared
Sep 03, 2010
SUPERIOR STARBURST REUSABLE SELF-ADHERING TENS/NMES/FES STIMULATING ELECTRODE
GXY
Electrode, Cutaneous
199d
Cleared
Aug 24, 2010
LEGEND POWER ADAPTER MODEL: 6475000
HBB
Motor, Drill, Pneumatic
120d
Cleared
Aug 19, 2010
DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULATOR PROBE, BIPOLAR SIDE BY SIDE
GXZ
Electrode, Needle
140d
Cleared
Aug 12, 2010
AESCULAP PEEK CRANIOFIX
GXR
Cover, Burr Hole
428d
Cleared
Aug 10, 2010
DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20
GXI
Probe, Radiofrequency Lesion
85d
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
Jun 25, 2010
4 CHANNELS MULTIPLE MODEL DIGITAL ELECTRICAL STIMULATOR, MODEL NUVOSTIM IV, WL-2504A
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
129d
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
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