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
4767 Neurology devices
Cleared
Feb 01, 1988
KONTRON E.E.G. MONITOR, SUPERMON MODULE 7265
GWQ
Full-montage Standard Electroencephalograph
335d
Cleared
Jan 28, 1988
HUDSON CRANINAL BURRS
HBE
Drills, Burrs, Trephines & Accessories (simple, Powered)
37d
Cleared
Jan 28, 1988
MEDTRONIC SNAP EASE MODEL 7795 CUTANEOUS ELECTRODE
GXY
Electrode, Cutaneous
35d
Cleared
Jan 19, 1988
H-H EXTERNAL VENTRICULAR DRAINAGE COLLECTION BAG
JXG
Shunt, Central Nervous System And Components
78d
Cleared
Jan 19, 1988
MODEL EEG 4400 WITH OPTIONAL ACCESSORIES
GWQ
Full-montage Standard Electroencephalograph
75d
Cleared
Dec 23, 1987
RANGE OF TITANIUM NEUROSURGERY INSTRUMENTS
HAO
Instrument, Surgical, Non-powered
43d
Cleared
Dec 18, 1987
HEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTRO
GYK
Instrument, Shunt System Implantation
93d
Cleared
Dec 17, 1987
RAYLOR(TM) DRILL STOP
HBE
Drills, Burrs, Trephines & Accessories (simple, Powered)
100d
Cleared
Dec 17, 1987
RANGE OF NEUROSURGICAL INSTRUMENTS IN TITANIUM
GZX
Instrument, Microsurgical
83d
Cleared
Dec 17, 1987
RANGE OF CROCODILE ACTION INSTRUMENTS
GZX
Instrument, Microsurgical
83d
Cleared
Nov 16, 1987
TECA/MEDELEC TTT THERMAL THRESHOLD TESTER
LLN
Device, Vibration Threshold Measurement
112d
Cleared
Nov 06, 1987
AESTHESIOMETER
GWI
Discriminator, Two-point
17d
Cleared
Oct 26, 1987
SMK SLUYTER-MEHTA CANNULAE, RF POLE, POLE,FLEXIBLE
GXI
Probe, Radiofrequency Lesion
294d
Cleared
Oct 26, 1987
NICOLET EXPERT SLEEP/WAKE ANALYSIS SYSTEM
GWQ
Full-montage Standard Electroencephalograph
55d
Cleared
Oct 26, 1987
ANEUROPLASTIC, ACRYLIC ANEURYOMORRHAPLY MATERIAL
JXH
Methyl Methacrylate For Aneurysmorrhaphy
46d
Cleared
Oct 26, 1987
CRANIOPLASTIC, ACRYLIC CRANIOPLASTY MATERIAL
GXP
Methyl Methacrylate For Cranioplasty
45d
Cleared
Oct 07, 1987
MODEL MPA MULTI PARAMETER ANALYSIS MONITORING SYS.
OLZ
Automatic Event Detection Software For Polysomnograph With Electroencephalograph
134d
Cleared
Oct 06, 1987
BIO-LOGIC BANKER
GWK
Conditioner, Signal, Physiological
112d
Cleared
Oct 06, 1987
MODIFIED #3587 RESUME SE-4/#3487 PISCES-QUAD
GZB
Stimulator, Spinal-cord, Implanted (pain Relief)
22d
Cleared
Sep 30, 1987
MEM-4104 EVOKED RESPONSE/ELECTROMYOGRAPHY RECORDER
GWL
Amplifier, Physiological Signal
216d
Cleared
Sep 28, 1987
CEDAR(TM) RETRACTOR RING
GZT
Retractor, Self-retaining, For Neurosurgery
20d
Cleared
Sep 18, 1987
CSF-FLOW CONTROL VALVE, ULTRA SMALL
JXG
Shunt, Central Nervous System And Components
35d
Cleared
Aug 07, 1987
LECTEC STIMULATING ELECTRODE
GXY
Electrode, Cutaneous
56d
Cleared
Aug 04, 1987
NOVAMETRIX MODEL 200 MAGSTIM
GWF
Stimulator, Electrical, Evoked Response
123d
Cleared
Aug 04, 1987
ULTRAPAC II SX PLUS (TM)
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
28d
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