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
4726 Neurology devices
Cleared
Mar 05, 2009
V-GRIP PLUS DETACHMENT CONTROLLER, MODEL VG503
HCG
Device, Neurovascular Embolization
62d
Cleared
Mar 04, 2009
CODMAN BACTISEAL EVD CATHETER SET, CODMAN BACTISEAL CLEAR EVD CATHETER SET
JXG
Shunt, Central Nervous System And Components
21d
Cleared
Feb 27, 2009
NIM 3.0
GWF
Stimulator, Electrical, Evoked Response
128d
Cleared
Feb 26, 2009
DX6605E-TENS, DX6605E-G, DX6609-G
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
220d
Cleared
Feb 20, 2009
SCRAMBLER ST 5 TENS DEVICE
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
294d
Cleared
Feb 20, 2009
PIGALILEO TOTAL HIP REPLACEMENT (THR) SOFTWARE APPLICATION V3.0
HAW
Neurological Stereotaxic Instrument
79d
Cleared
Feb 12, 2009
MERCI RETRIEVER, MODELS 90050, 90060, 90066, 90070, 90110, 90111, 90112, 90113
NRY
Catheter, Thrombus Retriever
30d
Cleared
Jan 30, 2009
IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR, MODEL: WL-2206B AND WL-2106E
LIH
Interferential Current Therapy
25d
Cleared
Jan 23, 2009
PRO-TECH DELIVERY SYSTEM ELECTRODES, MODEL TT-2000
GXY
Electrode, Cutaneous
262d
Cleared
Jan 21, 2009
UNIVERSAL ELECTRODES
GXY
Electrode, Cutaneous
30d
Cleared
Jan 08, 2009
PAIN VISION, MODEL PS-2100
LLN
Device, Vibration Threshold Measurement
457d
Cleared
Jan 02, 2009
MICRUS MICROCOLI SYSTEM, DELTAPLUSH, MODELS CPL, DPL
HCG
Device, Neurovascular Embolization
24d
Cleared
Dec 30, 2008
NICOLET CORTICAL STIMULATOR
GYC
Electrode, Cortical
438d
Cleared
Dec 22, 2008
CRANIAL PERFORATOR
HBF
Drills, Burrs, Trephines & Accessories (compound, Powered)
103d
Cleared
Dec 16, 2008
BIS INTERFACE FOR VITALOGIK PATIENT MONITORS
OLW
Index-generating Electroencephalograph Software
63d
Cleared
Dec 09, 2008
RUGALIFT, MODEL# V.2.1
NFO
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
550d
Cleared
Dec 08, 2008
MAGSTIM DOUBLE 70MM AIR FILM COIL, MODEL 3910-00
GWF
Stimulator, Electrical, Evoked Response
287d
Cleared
Dec 05, 2008
STARBAND
OAN
Orthosis, Cranial, Laser Scan
63d
Cleared
Nov 28, 2008
MEDISTIM XP, TYPE 281 AND MEDITENS XP, TYPE 458
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
136d
Cleared
Nov 28, 2008
GE ENTROPY SENSOR
GXY
Electrode, Cutaneous
87d
Cleared
Nov 25, 2008
MAKO SURGICAL TACTILE GUIDANCE SYSTEM VERSION 2.0
HAW
Neurological Stereotaxic Instrument
147d
Cleared
Nov 20, 2008
STRATA BURR HOLE VALVE, MODEL 42836 AND STRATA BURR HOLE SHUNT ASSEMBLY, MODEL 46836
JXG
Shunt, Central Nervous System And Components
35d
Cleared
Nov 10, 2008
TOP NEUROPOLE NEEDLE, MODEL SH, BL, SC, TC
GXI
Probe, Radiofrequency Lesion
236d
Cleared
Nov 05, 2008
COMPONENT NEUROMONITORING SYSTEM
OMA
Amplitude-integrated Electroencephalograph
281d
Cleared
Oct 31, 2008
STARLIGHT
OAN
Orthosis, Cranial, Laser Scan
29d
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