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

6334
Total
6279
Cleared
155d
Avg (2y)
1976
Since
6334 Neurology devices
1726–1750 of 6334
Cleared Nov 08, 2016
Cadwell AmpliScan
K161027 · Cadwell Industries, Inc.
OMA · Amplitude-integrated Electroencephalograph · 210d
Cleared Nov 04, 2016
Trex_HD
K162595 · Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
GWQ · Full-montage Standard Electroencephalograph · 50d
Cleared Nov 02, 2016
Durepair Dura Regeneration Matrix
K161370 · Medtronic Neurosurgery
GXQ · Dura Substitute · 169d
Cleared Oct 31, 2016
AxoGuard Nerve Connector
K162741 · Cook Biotech Incorporated
JXI · Cuff, Nerve · 31d
Cleared Oct 30, 2016
FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S, 5050ROC1W, 5050ROC2S, 5050ROC2W, 5050SQC1S, 5050SQC1W, 5050SQC2S, 5050SQC2W
K161282 · Medico Electrodes International , Ltd.
GXY · Electrode, Cutaneous · 177d
Cleared Oct 28, 2016
Codman EDS3 CSF External Drainage System
K162437 · Codman & Shurtleff, Inc.
JXG · Shunt, Central Nervous System And Components · 58d
Cleared Oct 27, 2016
Smart External Drain (SED) System
K161605 · Aqueduct Critical Care, Inc.
JXG · Shunt, Central Nervous System And Components · 139d
Cleared Oct 20, 2016
HICP200 Patient/Monitor Interconnect Cable
K161010 · Innerspace Neuro Solutions, Inc.
GWM · Device, Monitoring, Intracranial Pressure · 192d
Cleared Oct 19, 2016
TENS Electrodes
K160081 · Cathay Manufacturing Corp.
GXY · Electrode, Cutaneous · 278d
Cleared Oct 18, 2016
Neuromonitoring Kit
K161893 · SI-BONE, Inc.
PDQ · Neurosurgical Nerve Locator · 99d
Cleared Oct 14, 2016
ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip
K161912 · Asahi Intecc Co., Ltd.
MOF · Guide, Wire, Catheter, Neurovasculature · 94d
Cleared Oct 13, 2016
OTC TENS Device, Model PTS-IV
K161537 · Counter Scientific Development (Gz), Ltd.
NUH · Stimulator, Nerve, Transcutaneous, Over-the-counter · 132d
Cleared Oct 06, 2016
SimulCare II(TM)
K160246 · Xanacare Technologies, LLC
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 248d
Cleared Oct 05, 2016
Painmaster MCT Patch
K151995 · Newmark, Inc.
NUH · Stimulator, Nerve, Transcutaneous, Over-the-counter · 443d
Cleared Sep 30, 2016
Traxcess .007 Mini Guidewire
K161803 · MicroVention, Inc.
MOF · Guide, Wire, Catheter, Neurovasculature · 92d
Cleared Sep 27, 2016
Biopor Porous Polyethylene Implants
K161446 · Ceremed , Inc.
GWO · Plate, Cranioplasty, Preformed, Alterable · 125d
Cleared Sep 23, 2016
VSP Cranial System
K151285 · 3D Systems, Inc.
PPT · Cranial Surgical Planning And Instrument Guides · 498d
Cleared Sep 22, 2016
Ahead 300
K161068 · Brainscope Company, Inc.
PIW · Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid · 160d
Cleared Sep 22, 2016
Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems
K161992 · Integra LifeSciences Corporation
JXG · Shunt, Central Nervous System And Components · 65d
Cleared Sep 21, 2016
Solitaire Platinum Revascularization Device
K161879 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
NRY · Catheter, Thrombus Retriever · 75d
Cleared Sep 20, 2016
Personal Kinetigraph (PKG) System
K161717 · Gkc Manufacturing Pty, Ltd.
GYD · Transducer, Tremor · 90d
Cleared Sep 17, 2016
KARL STORZ Flexible Video-Neuro-Endoscope System
K161112 · KARL STORZ Endoscopy-America, Inc.
GWG · Endoscope, Neurological · 150d
Cleared Sep 15, 2016
TEMPEDY
K152946 · Seiratherm GmbH
NCX · System, Hypothermia, Intravenous, Cooling · 345d
Cleared Sep 15, 2016
HBOTC Muscle and Nerve Stimulator
K160255 · Hb Medical, Inc.
NUH · Stimulator, Nerve, Transcutaneous, Over-the-counter · 227d
Cleared Sep 14, 2016
StealthStation System with Cranial Software
K153660 · Medtronic Navigation, Inc.
HAW · Neurological Stereotaxic Instrument · 268d

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All categories 6334 GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief 605 GXY Electrode, Cutaneous 438 HAW Neurological Stereotaxic Instrument 417 JXG Shunt, Central Nervous System And Components 260 NUH Stimulator, Nerve, Transcutaneous, Over-the-counter 218 GWQ Full-montage Standard Electroencephalograph 189 HCG Device, Neurovascular Embolization 187 HCC Device, Biofeedback 172 GWF Stimulator, Electrical, Evoked Response 140 GZB Stimulator, Spinal-cord, Implanted (pain Relief) 133 NRY Catheter, Thrombus Retriever 117 GWM Device, Monitoring, Intracranial Pressure 105 QJP Catheter, Percutaneous, Neurovasculature 102 GWG Endoscope, Neurological 94 NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes 81