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
4744 Neurology devices
Cleared
Jan 12, 2005
DURAGEN II DURAL REGENERATION MATRIX
GXQ
Dura Substitute
30d
Cleared
Jan 05, 2005
MEDTRONIC SNT STEALTHSTATION AXIEM IMAGELESS KNEE MODULE
HAW
Neurological Stereotaxic Instrument
58d
Cleared
Dec 29, 2004
VISIOPLAST ACRYLIC RESIN
GXP
Methyl Methacrylate For Cranioplasty
113d
Cleared
Dec 21, 2004
ACCUDRAIN EXTERNAL CSF DRAINAGE SYSTEM
JXG
Shunt, Central Nervous System And Components
70d
Cleared
Dec 21, 2004
OLYMPUS ENDOARM
GWG
Endoscope, Neurological
39d
Cleared
Dec 21, 2004
MIMIX MP BONE VOID FILLER
GXP
Methyl Methacrylate For Cranioplasty
25d
Cleared
Dec 17, 2004
INFINITY ELECTROTHERAPY SYSTEM
LIH
Interferential Current Therapy
140d
Cleared
Dec 17, 2004
DOC BAND-POSTOP
MVA
Orthosis, Cranial
107d
Cleared
Dec 17, 2004
ANSPACH MINIMAL ACCESS SPINAL ATTACHMENT (MASA) SYSTEM
HBE
Drills, Burrs, Trephines & Accessories (simple, Powered)
72d
Cleared
Dec 14, 2004
POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM, MODELS SPV-140, SPV-300, SPV-400
JXG
Shunt, Central Nervous System And Components
92d
Cleared
Dec 09, 2004
PATHFINDER
HAW
Neurological Stereotaxic Instrument
189d
Cleared
Dec 09, 2004
AESCULAP T-BAR ANEURYSM CLIPS (TITANIUM & PHYNOX)
HCH
Clip, Aneurysm
35d
Cleared
Dec 01, 2004
DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE
GXQ
Dura Substitute
240d
Cleared
Nov 26, 2004
EZY-TRAVEL WRISTBAND
MVV
Device, Acupressure
149d
Cleared
Nov 23, 2004
COMBINATION POWERED ELECTRICAL MUSCLE STIMULATOR AND INTERFERENTIAL STIMULATOR, MODEL BMLS04-1
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
182d
Cleared
Nov 23, 2004
REPROCESSED DIAMOND BURS
NLN
Drills, Burrs, Trephines And Accessories (simple Powered), Reprocessed
123d
Cleared
Nov 18, 2004
BASBA E-MACHINE
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
198d
Cleared
Nov 17, 2004
FAMILY OF CRYSTAL 20 MONITORS MODEL #CS20-600,900,1300,1400,2400 & 120
OLV
Standard Polysomnograph With Electroencephalograph
111d
Cleared
Nov 17, 2004
SUBDURAL EVACUATING PORT SYSTEM CRANIAL ACCESS KIT (SEPS-CA), (SEPS-CAL), (SEPS-CAND),MODELS 11-0401 CA, 11-0401-CAL
JXG
Shunt, Central Nervous System And Components
78d
Cleared
Nov 17, 2004
GEM-TWIN TENS/ MODELS GM3XY/Z
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
57d
Cleared
Nov 16, 2004
DYNAMOMETER - MODEL FCE AND MODEL MSC
LBB
Dynamometer, Ac-powered
28d
Cleared
Nov 12, 2004
GELSPHERES MICROSPHERES AND BEAD BLOCK COMPRESSIBLE MICROSPHERES
HCG
Device, Neurovascular Embolization
87d
Cleared
Nov 03, 2004
TES-1 CONSTANT VOLTAGE ELECTRICAL STIMULATOR
GWF
Stimulator, Electrical, Evoked Response
65d
Cleared
Oct 26, 2004
SMK, CX, CXE, RCN
GXI
Probe, Radiofrequency Lesion
55d
Cleared
Oct 22, 2004
IPLAN!
HAW
Neurological Stereotaxic Instrument
122d
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