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
4744 Neurology devices
3051–3075 of 4744
Cleared Mar 05, 2004
AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE
K032278 · Ambu, Inc.
GXY · Electrode, Cutaneous · 225d
Cleared Mar 02, 2004
NAVIGUS UNIBODY FIDUCIAL MARKER SYSTEM, MODEL FM-4000
K033619 · Image-Guided Neurologics, Inc.
HAW · Neurological Stereotaxic Instrument · 105d
Cleared Feb 25, 2004
CODMAN DURAL GRAFT IMPLANT, MODELS 80-1471, 80-1472, 80-1473, 80-1474, 80-1475, 80-1476, 80-1477, 80-1478, 80-1480, 80-1
K033395 · Codman & Shurtleff, Inc.
GXO · Strip, Craniosynostosis, Preformed · 125d
Cleared Feb 25, 2004
BISX
K040183 · Aspect Medical Systems, Inc.
OLW · Index-generating Electroencephalograph Software · 29d
Cleared Feb 18, 2004
ZIMMER ORTHO GUIDANCE SYSTEMS- HIP INSTRUMENTS
K033223 · Zimmer, Inc.
HAW · Neurological Stereotaxic Instrument · 135d
Cleared Feb 17, 2004
VECTORVISION CRANIAL/ENT
K023651 · Brainlab AG
HAW · Neurological Stereotaxic Instrument · 475d
Cleared Feb 12, 2004
ZIMMER ORTHO GUIDANCE SYSTEMS- KNEE INSTRUMENTS
K033011 · Zimmer, Inc.
HAW · Neurological Stereotaxic Instrument · 139d
Cleared Feb 12, 2004
LEKSELL SURGIPLAN WITH IMAGEMERGE
K033340 · Elekta Instrument AB
HAW · Neurological Stereotaxic Instrument · 118d
Cleared Feb 06, 2004
SEDLINE WITH FRONTAL PSI
K033999 · Physiometrix, Inc.
OLW · Index-generating Electroencephalograph Software · 44d
Cleared Jan 30, 2004
MTS MULTIPROGRAM TRIAL STIMULATOR SYSTEM
K033757 · Advanced Neuromodulation Systems
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 60d
Cleared Jan 16, 2004
STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM
K032303 · Stryker Instruments
HBE · Drills, Burrs, Trephines & Accessories (simple, Powered) · 175d
Cleared Jan 15, 2004
EEG MONITOR WITH BIS, MODEL A-2000
K030267 · Aspect Medical Systems, Inc.
OLW · Index-generating Electroencephalograph Software · 353d
Cleared Jan 15, 2004
ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5
K033455 · Biomedical Life Systems, Inc.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 77d
Cleared Jan 13, 2004
MEDTRONIC PS MEDICAL STRATA NSC VALVE AND SHUNT ASSEMBLIES WITH AND WITHOUT BIOGLIDE
K033850 · Medtronic Neurosurgery
JXG · Shunt, Central Nervous System And Components · 33d
Cleared Jan 09, 2004
SAPPHIRE DETACHABLE FIBERED COIL SYSTEM, HELIX FIBERED, CYCLONE, MULTIPLE MODELS
K033372 · Micro Therapeutics, Inc.
HCG · Device, Neurovascular Embolization · 79d
Cleared Jan 07, 2004
WIRELESS INPUT UNIT, MODEL WEE-1000A SERIES
K033475 · Nihon Kohden America, Inc.
OLV · Standard Polysomnograph With Electroencephalograph · 65d
Cleared Dec 30, 2003
HYDROCOIL EMBOLIC SYSTEM (HES)
K033836 · MicroVention, Inc.
HCG · Device, Neurovascular Embolization · 20d
Cleared Dec 04, 2003
LAMITRODE SPINAL CORD STIMULATION LEADS
K033429 · Advanced Neuromodulation Systems
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 37d
Cleared Oct 31, 2003
BONE CEMENT RADIO-OPACIFIER
K032388 · Cardinalhealth
MYU · Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty · 88d
Cleared Oct 30, 2003
BONESOURCE HAC FAST SETTING CEMENT
K032366 · Stryker Instruments
GXP · Methyl Methacrylate For Cranioplasty · 90d
Cleared Oct 24, 2003
CAP BONE SUBSTITUTE MATERIAL
K032307 · Etex Corp.
GXP · Methyl Methacrylate For Cranioplasty · 91d
Cleared Oct 22, 2003
MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES)
K032590 · MicroVention, Inc.
HCG · Device, Neurovascular Embolization · 61d
Cleared Oct 15, 2003
EBI ACUMEN SURGICAL NAVIGATION SYSTEM
K031732 · Ebi, L.P.
HAW · Neurological Stereotaxic Instrument · 133d
Cleared Oct 06, 2003
MODIFICATION TO RENEW LEAD EXTENSION
K032751 · Advanced Neuromodulation Systems
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 31d
Cleared Oct 03, 2003
ANS AXXESS PERCUTANEOUS LEAD
K032034 · Advanced Neuromodulation Systems
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 94d

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All categories 4744 HAW Neurological Stereotaxic Instrument 342 GXY Electrode, Cutaneous 307 GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief 279 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 100 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