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
1751–1775 of 6334
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
Cleared Jul 22, 2016
ReWalk(TM)
K160987 · Rewalk Robotics, Inc.
PHL · Powered Exoskeleton · 105d
Cleared Jul 20, 2016
St. Louis Band
K161138 · Orthomerica Products, Inc.
OAN · Orthosis, Cranial, Laser Scan · 89d
Cleared Jul 19, 2016
Ekso™ (version 1.1) and Ekso GT™ (version 1.2)
K161443 · Ekso Bionics, Inc.
PHL · Powered Exoskeleton · 55d
Not Cleared Jul 15, 2016
EPIC ClearView System
DEN150004 · Epic Research & Diagnostics, Inc.
PNA · Evoked Photon Image Capture Device · 549d
Cleared Jul 14, 2016
PMT Platinum Depthalon Depth Electrode
K151790 · Pmt Corporation
GZL · Electrode, Depth · 379d
Cleared Jul 13, 2016
EXACTECH GPS
K152764 · Blue Ortho
HAW · Neurological Stereotaxic Instrument · 293d
Cleared Jul 12, 2016
Penumbra System ACE 68 Reperfusion Catheter
K161640 · Penumbra, Inc.
NRY · Catheter, Thrombus Retriever · 28d

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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