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
4727 Neurology devices
Cleared
May 08, 2008
MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 CERECYTE, MODEL CDF
HCG
Device, Neurovascular Embolization
83d
Cleared
May 02, 2008
TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE OR TRUFILL DCS SYRINGE II, ALSO KNOWN AS THE TRUFILL DCS ORBIT
HCG
Device, Neurovascular Embolization
28d
Cleared
May 01, 2008
DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES
GXY
Electrode, Cutaneous
136d
Cleared
Apr 30, 2008
EMAX 2 PLUS SYSTEM, MODEL EMAX 2 PLUS MOTOR, EMAX 2 CONSOLE>FIRMWARE UPGRADE, EMAX 2 FP FOOT PEDAL
HBE
Drills, Burrs, Trephines & Accessories (simple, Powered)
40d
Cleared
Apr 29, 2008
MPS OXIPORT AND MPS OXIPORT PLUS
GWM
Device, Monitoring, Intracranial Pressure
249d
Cleared
Apr 25, 2008
NEUROMETRIX ADVANCE
JXE
Device, Nerve Conduction Velocity Measurement
470d
Cleared
Apr 24, 2008
TARGET STERILE ELECTRODE
GXY
Electrode, Cutaneous
206d
Cleared
Apr 04, 2008
INTERX 1000/DERMA 200 STIMULATOR FOR COSMETIC USE
NFO
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
437d
Cleared
Apr 04, 2008
VIVOSONIC NEUROSCREEN
GWJ
Stimulator, Auditory, Evoked Response
86d
Cleared
Apr 02, 2008
CONMED LINVATEC OSPREY DRILL SYSTEM
HBC
Motor, Drill, Electric
43d
Cleared
Mar 27, 2008
MODIFICATION TO: DATEX-OHMEDA S/5 ENTROPY MODULE, E-ENTROPY AND ACCESSORIES
OLW
Index-generating Electroencephalograph Software
631d
Cleared
Mar 13, 2008
AEMED STIMPAD ACU-TENS TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR, MODEL 021999
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
328d
Cleared
Mar 11, 2008
KFH ENERGY, MODEL: E1
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
139d
Cleared
Mar 07, 2008
TENS/IF 14
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
245d
Cleared
Mar 04, 2008
BAXANO ULTRA LOW PROFILE RONGEUR
HAE
Rongeur, Manual
11d
Cleared
Feb 28, 2008
LIMITED ARTIFACT SKULL PIN, MODEL 0107
HBL
Holder, Head, Neurosurgical (skull Clamp)
111d
Cleared
Feb 28, 2008
SMART COUPLER, MODEL M015401
GWJ
Stimulator, Auditory, Evoked Response
87d
Cleared
Feb 28, 2008
EEG NEUROAMP, MODEL CS10137
HCC
Device, Biofeedback
71d
Cleared
Feb 28, 2008
MODIFICATION TO:NESS L300
GZI
Stimulator, Neuromuscular, External Functional
30d
Cleared
Feb 26, 2008
MICRUS MICROCOIL SYSTEMS
HCG
Device, Neurovascular Embolization
81d
Cleared
Feb 22, 2008
NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGES
HBA
Neurosurgical Paddie
65d
Cleared
Feb 15, 2008
MODEL I-2000 MONITOR
OLT
Non-normalizing Quantitative Electroencephalograph Software
175d
Cleared
Feb 14, 2008
FACTS HAND AND PINCH GRIP COMBO
LBB
Dynamometer, Ac-powered
98d
Cleared
Feb 14, 2008
PVA PLUS VIAL PVA FOAM EMBOLIZATION PARTICLES, PVA PLUS CONVENIENCE KIT PVA EMBOLIZATION PARTICLES
HCG
Device, Neurovascular Embolization
71d
Cleared
Feb 07, 2008
PROSTIM 1000/2000
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
62d
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