FDA Review Panel · NE

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
4750 Neurology devices
3401–3425 of 4750
Cleared Aug 18, 1999
DIGITAL RING ELECTRDE
K991771 · Neuro Supplies, Inc.
GXY · Electrode, Cutaneous · 86d
Cleared Aug 18, 1999
CUTANEOUS (DISC) ELECTRODE
K991772 · Neuro Supplies, Inc.
GXY · Electrode, Cutaneous · 86d
Cleared Aug 13, 1999
PARALLAX TRACER RADIOPAQUE PARTICLES
K991893 · Parallax Medical, Inc.
MYU · Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty · 71d
Cleared Aug 13, 1999
NORODYN 8000 SEMG SYSTEM, ND-8000
K992439 · Myotronics-Noromed, Inc.
HCC · Device, Biofeedback · 22d
Cleared Aug 12, 1999
REMOTE INTRODUCER, MODEL PI-1000
K990907 · Image-Guided Neurologics, Inc.
HAW · Neurological Stereotaxic Instrument · 147d
Cleared Aug 12, 1999
EXPRESSEYE
K992473 · Optomotor Laboratories
GWN · Nystagmograph · 17d
Cleared Aug 06, 1999
H20- TETHERED OPTION
K992291 · Grass-Telefactor Product Group
OLV · Standard Polysomnograph With Electroencephalograph · 30d
Cleared Aug 04, 1999
EXCEL PHOTIC STIMULATOR, MODEL (XLPS-1)
K991903 · Excel Tech. , Ltd.
GWE · Stimulator, Photic, Evoked Response · 61d
Cleared Aug 03, 1999
EYE TRAK TM, COMPUTERIZED ELECTRONYSTAGMOGRAPH (ENG), MODEL ETV-XXXX
K991642 · Bertec Corp.
GWN · Nystagmograph · 82d
Cleared Jul 30, 1999
KOMET XK-95 PERFORATOR MOTOR (MI-102)
K991625 · Komet Medical
HBB · Motor, Drill, Pneumatic · 80d
Cleared Jul 28, 1999
ICS MEDICAL CHARTR ENG/VNG DIAGNOSTIC SYSTEM
K991497 · Ics Medical Corp.
GWN · Nystagmograph · 90d
Cleared Jul 23, 1999
BIOSACA SYSTEM, MODEL 800
K991446 · Biosys AB (Publ)
OLV · Standard Polysomnograph With Electroencephalograph · 88d
Cleared Jul 20, 1999
ELEKTA STEREOTACTIC GUIDE
K991636 · Elekta Instrument AB
HAW · Neurological Stereotaxic Instrument · 69d
Cleared Jul 20, 1999
SYNTHES CRANIAL FLAP TWIST CLAMP
K991860 · Synthes (Usa)
GXN · Plate, Cranioplasty, Preformed, Non-alterable · 49d
Cleared Jul 20, 1999
SYNTHES CRANIAL FLAP TUBE CLAMP
K992000 · Synthes (Usa)
GXN · Plate, Cranioplasty, Preformed, Non-alterable · 35d
Cleared Jul 14, 1999
NEUROTREND MULTIPARAMETER SENSOR, C7004S, TO OPERATE WITH PARATREND 7+ MULTIPARAMETER SENSOR, MPM7001S, AND SATELLITE MS
K980380 · Diametrics Medical, Ltd.
GWM · Device, Monitoring, Intracranial Pressure · 527d
Cleared Jul 12, 1999
SPINE APPLICATIONS FOR THE MAYFIELD/ACCISS OPERATING ARM AND OPTICAL ACCISS SYSTEMS MODULE, MAYFIELD/ACCISS SPINE RING A
K991267 · Ohio Medical Instrument Co., Inc.
HAW · Neurological Stereotaxic Instrument · 90d
Cleared Jul 12, 1999
XLTEK POLYSOMNOGRAPHY HEADBOX, MODEL # PSG-40
K991900 · Excel Tech. , Ltd.
OLV · Standard Polysomnograph With Electroencephalograph · 38d
Cleared Jul 09, 1999
CODMAN MICROSENSOR VENTRICULAR CATHETER KIT
K991222 · Johnson & Johnson Professionals, Inc.
GWM · Device, Monitoring, Intracranial Pressure · 88d
Cleared Jul 08, 1999
VIEWPOINT TOOLS- STERRAD
K983764 · Philips Medical Systems (Cleveland), Inc.
HAW · Neurological Stereotaxic Instrument · 255d
Cleared Jul 06, 1999
DURAGEN DURAL GRAFT MATRIX
K982180 · Integra Lifesciences Corp.
GXQ · Dura Substitute · 379d
Cleared Jun 25, 1999
FRAMELESS NEUROMATE
K991081 · Integrated Surgical Systems, Inc.
HAW · Neurological Stereotaxic Instrument · 86d
Cleared Jun 24, 1999
SIEMENS INFINITY EEG POD
K991012 · Siemens Medical Solutions USA, Inc.
OLT · Non-normalizing Quantitative Electroencephalograph Software · 90d
Cleared Jun 24, 1999
RENEW LEAD EXTENSION
K991784 · Advanced Neuromodulation Systems
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 30d
Cleared Jun 23, 1999
Z KAT FLUROTACTIC GUIDANCE SYSTEM MKI
K984298 · Z-Kat, Inc.
HAW · Neurological Stereotaxic Instrument · 203d

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All categories 4750 HAW Neurological Stereotaxic Instrument 342 GXY Electrode, Cutaneous 307 GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief 281 JXG Shunt, Central Nervous System And Components 224 NUH Stimulator, Nerve, Transcutaneous, Over-the-counter 211 HCG Device, Neurovascular Embolization 173 GWQ Full-montage Standard Electroencephalograph 142 NRY Catheter, Thrombus Retriever 114 GZB Stimulator, Spinal-cord, Implanted (pain Relief) 113 GWF Stimulator, Electrical, Evoked Response 101 QJP Catheter, Percutaneous, Neurovasculature 97 GWG Endoscope, Neurological 87 NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes 74 GWM Device, Monitoring, Intracranial Pressure 71 OBP Transcranial Magnetic Stimulator 67