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
Jan 17, 2013
RESORB-X G
GWO
Plate, Cranioplasty, Preformed, Alterable
230d
Cleared
Jan 11, 2013
INFRASCANNER
OPT
Infrared Hematoma Detector
287d
Cleared
Jan 11, 2013
POWEREASE SYSTEM
HBE
Drills, Burrs, Trephines & Accessories (simple, Powered)
84d
Cleared
Jan 10, 2013
CRYO-TOUCH IV
GXH
Device, Surgical, Cryogenic
57d
Cleared
Jan 07, 2013
BRAINSWAY DEEP TMS SYSTEM
OBP
Transcranial Magnetic Stimulator
161d
Cleared
Dec 27, 2012
NESS L300 SYSTEM KIT, LEF MODEL LG3-5100
GZI
Stimulator, Neuromuscular, External Functional
107d
Cleared
Dec 21, 2012
GEMORE TRUE SINE INTERFERENTIAL STIMULATOR
LIH
Interferential Current Therapy
88d
Cleared
Dec 21, 2012
GEM-STIM COMBO STIMULATOR
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
88d
Cleared
Dec 20, 2012
g.HIamp
GWL
Amplifier, Physiological Signal
63d
Cleared
Dec 19, 2012
NEURODYN RUBY MUSCLE STIMULATOR, NEURODYN AUSSIE MUSCLE STIMULATOR
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
226d
Cleared
Dec 19, 2012
PMT TRUSCAN SURFACE ELECTRODE
GXY
Electrode, Cutaneous
135d
Cleared
Dec 17, 2012
SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTS
HAW
Neurological Stereotaxic Instrument
145d
Cleared
Nov 30, 2012
TARGET DETACHABLE COIL
HCG
Device, Neurovascular Embolization
29d
Cleared
Nov 30, 2012
SOLITAIRE 2 REVASCULARIZATION DEVICE
NRY
Catheter, Thrombus Retriever
29d
Cleared
Nov 26, 2012
SENSUS ELECTRODE
GXY
Electrode, Cutaneous
159d
Cleared
Nov 21, 2012
VECTTOR VT-200
LIH
Interferential Current Therapy
169d
Cleared
Nov 20, 2012
HEALTHMATEFOREVER
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
158d
Cleared
Nov 09, 2012
PSG-1100 SLEEP DIAGNOSTIC SYSTEM
GWQ
Full-montage Standard Electroencephalograph
231d
Cleared
Oct 31, 2012
MODIFIED TREVO RETRIEVER
NRY
Catheter, Thrombus Retriever
78d
Cleared
Oct 17, 2012
QBTES
LQD
Recorder, Attention Task Performance
90d
Cleared
Oct 15, 2012
REUSABLE CUTANEOUS ELECTRODE
GXY
Electrode, Cutaneous
150d
Cleared
Oct 12, 2012
BIOMET MICROFIXATION NEURO PLATING SYSTEM
GWO
Plate, Cranioplasty, Preformed, Alterable
133d
Cleared
Sep 27, 2012
TYPE 1077 ACCUSCREEN
GWJ
Stimulator, Auditory, Evoked Response
73d
Cleared
Sep 27, 2012
KARL STORZ NAVIGATIONPANEL UNIT (NPU) SYSTEM
HAW
Neurological Stereotaxic Instrument
73d
Cleared
Sep 25, 2012
STERLING MEDICAL IMPULSE 3 STIMULATOR
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
147d
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