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
4715 Neurology devices
1701–1725 of 4715
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
Cleared Sep 11, 2016
NeuroStar TMS Therapy System
K161519 · Neuronetics, Inc.
OBP · Transcranial Magnetic Stimulator · 101d
Cleared Sep 09, 2016
Self-retaining Retractor
K161004 · Fetzer Medical GmbH & Co. KG
GZT · Retractor, Self-retaining, For Neurosurgery · 151d
Cleared Sep 07, 2016
Symmetry Sharp Kerrison Rongeur
K161744 · Symmetry Surgical, Inc.
HAE · Rongeur, Manual · 75d
Not Cleared Sep 02, 2016
Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm, Trevo XP ProVue Retriever 3x20mm, Trevo XP ProVue Retriever 6x25mm, Trevo XP ProVue Retriever 4x30mm
DEN150049 · Concentric Medical, Inc.
POL · Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment · 312d
Cleared Aug 31, 2016
HydroCoil Embolic System (HES)
K161367 · MicroVention, Inc.
HCG · Device, Neurovascular Embolization · 106d
Cleared Aug 31, 2016
MicroPlex Coil System (MCS) - HyperSoft 3D
K161452 · MicroVention, Inc.
HCG · Device, Neurovascular Embolization · 97d
Cleared Aug 26, 2016
LCCS Disposable RF Electrode, LCCS Reusable RF Electrode
K152642 · Lccs Products Limited
GXI · Probe, Radiofrequency Lesion · 346d
Cleared Aug 26, 2016
Freedom Spinal Cord Stimulator System
K160600 · Stimwave Technologies Incorporated
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 177d
Cleared Aug 23, 2016
sTMS mini
K161663 · Eneura, Inc.
OKP · Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache · 68d
Not Cleared Aug 22, 2016
ImPACT Computerized Neurocognitive Concussion Management Aid
DEN150037 · Impact Applications, Inc.
POM · Computerized Cognitive Assessment Aid For Concussion · 377d
Cleared Aug 19, 2016
Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit with Tuohy-Borst Adapter,Codman Microsensor Metal Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit
K153347 · Codman & Shurtleff, Inc.
GWM · Device, Monitoring, Intracranial Pressure · 273d
Cleared Aug 11, 2016
Adhesive Electrodes
K160138 · Gmdasz Manufacturing Co., Ltd.
GXY · Electrode, Cutaneous · 203d
Cleared Aug 08, 2016
Cerafix Dura Substitute
K161278 · Acera Surgical, Inc.
GXQ · Dura Substitute · 94d
Cleared Aug 04, 2016
Fehling-Punches
K153243 · Fehling Instruments GmbH & Co. KG
HAE · Rongeur, Manual · 269d
Not Cleared Aug 01, 2016
Nautilus BrainPulse 1000
DEN140040 · Jan Medical, Inc.
POP · Cranial Motion Measurement Device · 587d
Cleared Jul 27, 2016
HANAROCare ReJu
K160893 · M.I. Tech Co., Ltd.
NUH · Stimulator, Nerve, Transcutaneous, Over-the-counter · 118d
Cleared Jul 23, 2016
Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs
K161154 · Spr Therapeutics, LLC
NHI · Stimulator, Nerve, Electrical, Percutaneous (pens), For Pain Relief · 89d
Cleared Jul 22, 2016
ELAN 4 Motor System
K152960 · Aesculap, Inc.
HBC · Motor, Drill, Electric · 289d

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All categories 4715 HAW Neurological Stereotaxic Instrument 341 GXY Electrode, Cutaneous 305 GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief 276 JXG Shunt, Central Nervous System And Components 222 NUH Stimulator, Nerve, Transcutaneous, Over-the-counter 211 HCG Device, Neurovascular Embolization 173 GWQ Full-montage Standard Electroencephalograph 140 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 86 NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes 74 GWM Device, Monitoring, Intracranial Pressure 71 OBP Transcranial Magnetic Stimulator 67