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
4745 Neurology devices
Cleared
Dec 20, 2002
RHYTHMLINK INTERNATIONAL SUBDERMAL NEEDLE ELECTRODES
GXZ
Electrode, Needle
108d
Cleared
Dec 09, 2002
SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR HIP APPLICATIONS
HAW
Neurological Stereotaxic Instrument
192d
Cleared
Dec 04, 2002
QUICKSET MIMIX BONE VOID FILLER
GXP
Methyl Methacrylate For Cranioplasty
29d
Cleared
Nov 19, 2002
ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS02-9
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
84d
Cleared
Nov 19, 2002
ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-10
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
76d
Cleared
Nov 19, 2002
THE BIOPLATE BATTERY POWERED DRILL
HBC
Motor, Drill, Electric
71d
Cleared
Nov 08, 2002
PRECLUDE MVP DURA SUBSTITUTE
GXQ
Dura Substitute
184d
Cleared
Oct 31, 2002
DIGITAL TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR, MODEL EV-803 DIGITAL TENS
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
238d
Cleared
Oct 25, 2002
VECTORVISION CT-FREE KNEE
HAW
Neurological Stereotaxic Instrument
184d
Cleared
Oct 21, 2002
ANSPACH POWERED KERRISON SYSTEM (PKS)
HAD
Rongeur, Powered
48d
Cleared
Oct 21, 2002
CRANIOCUT
HBE
Drills, Burrs, Trephines & Accessories (simple, Powered)
46d
Cleared
Oct 18, 2002
FRAMELOCK
HBG
Drills, Burrs, Trephines & Accessories (manual)
88d
Cleared
Oct 17, 2002
SMITH & NEPHEW IMAGE SURGICAL INSTRUMENTS FOR TRAUMA APPLICATIONS
HAW
Neurological Stereotaxic Instrument
136d
Cleared
Oct 08, 2002
OLYMPUS NEUROSCOPE, MODELS S-1349/1, S-1349/2, S-1349/3 AND S-1349/4
GWG
Endoscope, Neurological
235d
Cleared
Oct 08, 2002
MODEL 4310 PSARRAY2 EEG ELECTRODE
GXY
Electrode, Cutaneous
221d
Cleared
Oct 04, 2002
PSA4000 EEG MONITOR WITH FRONTAL PSI
OLW
Index-generating Electroencephalograph Software
217d
Cleared
Sep 25, 2002
NAVIGUS MANUAL DISPOSABLE MICRODRIVE WITH DIGITAL DISPLAY, MODELS MI-1000 & MI-1010
HAW
Neurological Stereotaxic Instrument
89d
Cleared
Sep 24, 2002
ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-4
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
203d
Cleared
Sep 10, 2002
XLTEK SLEEP SYSTEM
OLV
Standard Polysomnograph With Electroencephalograph
78d
Cleared
Sep 09, 2002
IPLAN
HAW
Neurological Stereotaxic Instrument
194d
Cleared
Sep 06, 2002
MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES) WITH THE HYDROLINK SYRINGE KIT
HCG
Device, Neurovascular Embolization
18d
Cleared
Aug 22, 2002
CONTOUR SE MICROSPHERES
HCG
Device, Neurovascular Embolization
28d
Cleared
Aug 20, 2002
MSS-28CS-301/701 NEEDLESCOPE
GWG
Endoscope, Neurological
280d
Cleared
Aug 19, 2002
SMITH & NEPHEW IMAGE GUIDED SURGICAL SYSTEM FOR KNEE APPLICATIONS
HAW
Neurological Stereotaxic Instrument
24d
Cleared
Aug 13, 2002
96 CHANNEL EEG HEADBOX MODEL EMU96
GWQ
Full-montage Standard Electroencephalograph
90d
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