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
Jun 22, 2004
NAVITRACK SYSTEM - S&N IMAGE FREE HIP, MODEL PRO-03017
HAW
Neurological Stereotaxic Instrument
29d
Cleared
Jun 22, 2004
CODMAN DURAFORM DURAL GRAFT IMPLANT
GXQ
Dura Substitute
15d
Cleared
Jun 21, 2004
SYNTHES (USA) PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANTS
GXN
Plate, Cranioplasty, Preformed, Non-alterable
192d
Cleared
Jun 15, 2004
MEDTRONIC PS MEDICAL STRATA VALVE
JXG
Shunt, Central Nervous System And Components
64d
Cleared
Jun 10, 2004
MODIFICATION TO HAKIM PRECISION VALVE SYSTEM, HAKIM PROGRAMMABLE VALVE SYSTEM, HAKIM MICRO PROGRAMMABLE VALVE SYSTEM, SI
JXG
Shunt, Central Nervous System And Components
27d
Cleared
Jun 03, 2004
NAVIGUS PASSIVE PROBE (BL), MODEL NP-2000
HAW
Neurological Stereotaxic Instrument
64d
Cleared
Jun 01, 2004
NIC36 AMPLIFIER
GWL
Amplifier, Physiological Signal
25d
Cleared
May 20, 2004
L-TENS
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
17d
Cleared
May 19, 2004
BONE CEMENT FOR CRANIOPLASTY
GXP
Methyl Methacrylate For Cranioplasty
117d
Cleared
May 10, 2004
ENVOY PATIENT MONITOR
OMC
Reduced- Montage Standard Electroencephalograph
504d
Cleared
Apr 29, 2004
INTERFERENTIAL STIMULATOR, MODEL BMLS03-6
LIH
Interferential Current Therapy
30d
Cleared
Apr 20, 2004
LICOX PMO BRAIN MONITORING SYSTEM
GWM
Device, Monitoring, Intracranial Pressure
78d
Cleared
Apr 15, 2004
BMR NEUROTECH BACK TENS AND LUMBAR SUPPORT DEVICE. TYPE 294
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
507d
Cleared
Apr 15, 2004
ANSPACH MRI SAFE SURGICAL DRILL SYSTEM
HBB
Motor, Drill, Pneumatic
79d
Cleared
Apr 01, 2004
STRYKER RF ELECTRODES AND CANNULAE
GXI
Probe, Radiofrequency Lesion
241d
Cleared
Apr 01, 2004
STRYKER INTERVENTIONAL PAIN RF GENERATOR
GXD
Generator, Lesion, Radiofrequency
220d
Cleared
Mar 31, 2004
AESCULAP ABSORBABLE CRANIOFIX
GXR
Cover, Burr Hole
76d
Cleared
Mar 25, 2004
POLYETHER URETHANE MATERIAL CHANGE IN NEUROSTIMULATION LEADS
GZB
Stimulator, Spinal-cord, Implanted (pain Relief)
21d
Cleared
Mar 25, 2004
RAPID PROGRAMMER
GZB
Stimulator, Spinal-cord, Implanted (pain Relief)
17d
Cleared
Mar 25, 2004
MODIFICATION TO SAPPHIRE DETACHABLE COIL SYSTEM (TETRIS 3-D)
HCG
Device, Neurovascular Embolization
8d
Cleared
Mar 18, 2004
ALICE 5
OLZ
Automatic Event Detection Software For Polysomnograph With Electroencephalograph
10d
Cleared
Mar 16, 2004
SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE
GXI
Probe, Radiofrequency Lesion
83d
Cleared
Mar 15, 2004
ANSPACH ADVANCED MICRO SAW ATTACHMENTS
HBE
Drills, Burrs, Trephines & Accessories (simple, Powered)
61d
Cleared
Mar 12, 2004
EMU128S, MODEL EX-NW-128S
GWQ
Full-montage Standard Electroencephalograph
28d
Cleared
Mar 11, 2004
NAVIPRO KNEE SOFTWARE MODULE
HAW
Neurological Stereotaxic Instrument
111d
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