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
4732 Neurology devices
Cleared
Nov 03, 2006
MODIFICATION TO DUREPAIR DURA REGENERATION MATRIX
GXQ
Dura Substitute
22d
Cleared
Oct 31, 2006
MAGPRO, MODEL R30
GWF
Stimulator, Electrical, Evoked Response
141d
Cleared
Oct 31, 2006
CHRONOS VISION EYE TRACKING DEVICE (C-ETD)
GWN
Nystagmograph
106d
Cleared
Oct 31, 2006
PATIENT CONTOURED MESH (PCM)
GXN
Plate, Cranioplasty, Preformed, Non-alterable
61d
Cleared
Oct 26, 2006
STRYKER ARIA PNEUMATIC SYSTEM
HBB
Motor, Drill, Pneumatic
129d
Cleared
Oct 19, 2006
NIOBE MAGNETIC NAVIGATION SYSTEM W/NAVIGANT WORKSTATION
NDQ
System, Catheter Or Guidewire, Steerable (magnetic)
195d
Cleared
Oct 16, 2006
CODMAN VPV SYSTEM, MODEL 82-3192
JXG
Shunt, Central Nervous System And Components
105d
Cleared
Oct 13, 2006
NET-2000 MICROCURRENT STIMULATOR
QJQ
Cranial Electrotherapy Stimulator To Treat Insomnia And/or Anxiety
266d
Cleared
Oct 13, 2006
MEDRELIEF ST SERIES, MODELS RT-50, ST-100, ST 150, ST-200, ST-300
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
213d
Cleared
Oct 06, 2006
PIGALILEO TOTAL KNEE REPLACEMENT (TKR) SYSTEM
HAW
Neurological Stereotaxic Instrument
143d
Cleared
Sep 29, 2006
CODMAN EDS 3 CSF EXTERNAL DRAINAGE SYSTEM, MODELS 82-1730, 82-1731, 82-1732, 82-1733, 82-1735, 82-1738
JXG
Shunt, Central Nervous System And Components
115d
Cleared
Sep 27, 2006
MONITORR ICP EXTERNAL DRAINAGE AND MONITORING SYSTEMS
JXG
Shunt, Central Nervous System And Components
26d
Cleared
Sep 27, 2006
OWL URF-3AP
GXD
Generator, Lesion, Radiofrequency
12d
Cleared
Sep 26, 2006
MAGSTIM 200-2
GWF
Stimulator, Electrical, Evoked Response
182d
Cleared
Sep 22, 2006
STRYKER INJECTABLE CEMENT
GXP
Methyl Methacrylate For Cranioplasty
185d
Cleared
Sep 22, 2006
ACTICAL
GWK
Conditioner, Signal, Physiological
171d
Cleared
Sep 20, 2006
NAVIVISION
HAW
Neurological Stereotaxic Instrument
61d
Cleared
Sep 19, 2006
PVA PLUS, MAXISTAT PVA, MICROSTAT PVA FOAM EMBOLIZATION PARTICLES
KRD
Device, Vascular, For Promoting Embolization
85d
Cleared
Sep 15, 2006
MEDTRONIC PS MEDICAL STRATA TYPE VALUE
JXG
Shunt, Central Nervous System And Components
184d
Cleared
Sep 15, 2006
AESCULAP NEURO PATTIES
HBA
Neurosurgical Paddie
29d
Cleared
Sep 05, 2006
LAPDOC I
HAW
Neurological Stereotaxic Instrument
127d
Cleared
Aug 31, 2006
RF LESION CANNULA, RF THERMOLESION CANNULA, THERMOLESION CANNULA, X-RAY CONTRAST CANNULA, CANNULA, FACET DENERATION NEED
GXI
Probe, Radiofrequency Lesion
197d
Cleared
Aug 31, 2006
AXIEM IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM
HAW
Neurological Stereotaxic Instrument
120d
Cleared
Aug 31, 2006
VITALSENSE XHR
GWK
Conditioner, Signal, Physiological
59d
Cleared
Aug 28, 2006
QUADRATENS, MODEL QT-42
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
63d
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