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
4747 Neurology devices
Cleared
Apr 05, 2002
MIETHKE SHUNT SYSTEM
HCA
Catheter, Ventricular
30d
Cleared
Apr 04, 2002
MAYFIELD/ACCISS OPERATING ARM SYSTEM AND MAYFIELD/OPTICAL ACCISS SYSTEM
HAW
Neurological Stereotaxic Instrument
170d
Cleared
Apr 04, 2002
ORTHOPILOT 2
HAW
Neurological Stereotaxic Instrument
157d
Cleared
Mar 28, 2002
CODMAN HAKIM SHUNT SYSTEMS
JXG
Shunt, Central Nervous System And Components
27d
Cleared
Mar 18, 2002
PAEDISCOPE, MODEL # P010A AND PF011A
GWG
Endoscope, Neurological
90d
Cleared
Mar 14, 2002
VECTORVISION TRAUMA
HAW
Neurological Stereotaxic Instrument
225d
Cleared
Mar 01, 2002
AESCULAP -MIETHKE SHUNT SYSTEM
JXG
Shunt, Central Nervous System And Components
330d
Cleared
Feb 08, 2002
SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR KNEE APPLICATIONS
HAW
Neurological Stereotaxic Instrument
161d
Cleared
Feb 08, 2002
MODIFICATION OF THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM
GXN
Plate, Cranioplasty, Preformed, Non-alterable
29d
Cleared
Feb 07, 2002
FAST SET PUTTY
GXP
Methyl Methacrylate For Cranioplasty
181d
Cleared
Feb 05, 2002
LIFECARE 5*5 CM SQUARE, LIFECARE 4*4 CM SQUARE, LIFECARE 5 CM ROUND, LIFECARE 7.5 CM ROUND, LIFECARE 4*6 CM OVAL
GXY
Electrode, Cutaneous
188d
Cleared
Jan 31, 2002
MATRIX DETACHABLE COILS
HCG
Device, Neurovascular Embolization
147d
Cleared
Jan 31, 2002
APEX MEDICAL MINI TENS
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
27d
Cleared
Jan 24, 2002
PERCUTANEOUS INTRODUCER SET, MODEL 042294 AND KIT MODEL 3550-18
GZB
Stimulator, Spinal-cord, Implanted (pain Relief)
128d
Cleared
Jan 17, 2002
MODIFICATION OF NC-STAT
JXE
Device, Nerve Conduction Velocity Measurement
91d
Cleared
Jan 10, 2002
DATEX-OHMEDA S/5 BIS MODULE, M-BIS AND ACCESSORIES
OLW
Index-generating Electroencephalograph Software
90d
Cleared
Dec 21, 2001
MODIFICATION TO: INJECTABLE MIMIX
GXP
Methyl Methacrylate For Cranioplasty
134d
Cleared
Dec 14, 2001
MODIFICATION TO:APEX MEDICAL IF-4100
GXY
Electrode, Cutaneous
28d
Cleared
Dec 11, 2001
SONDREX P.A.L. SYSTEM
HCC
Device, Biofeedback
306d
Cleared
Dec 10, 2001
THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM
GXN
Plate, Cranioplasty, Preformed, Non-alterable
90d
Cleared
Dec 06, 2001
MODIFICATION TO LEKSELL SURGIPLAN WITH ATLASPACE
HAW
Neurological Stereotaxic Instrument
15d
Cleared
Dec 05, 2001
MEDTRONIC INVISX BURR HOLE LOCK, MODEL 60520
GXN
Plate, Cranioplasty, Preformed, Non-alterable
90d
Cleared
Nov 08, 2001
SPECTRUM VENTRICULAR CATHETER
NHC
Catheter, Ventricular (containing Antibiotic Or Antimicrobial Agents)
150d
Cleared
Oct 30, 2001
HEMI-ARC SURGICAL NAVIGATOR
HAW
Neurological Stereotaxic Instrument
29d
Cleared
Oct 29, 2001
MICROPLEX COIL SYSTEM
HCG
Device, Neurovascular Embolization
111d
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