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
4706 Neurology devices
1301–1325 of 4706
Cleared Mar 13, 2019
AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access Catheter 068 x 125cm, AXS Catalyst Distal Access Catheter 068 x 132cm
K183463 · Stryker
DQY · Catheter, Percutaneous · 89d
Cleared Mar 13, 2019
AXS Catalyst 7 Distal Access Catheter (068 x 115cm, 068 x 125cm, 068 x 132cm)
K183464 · Stryker
NRY · Catheter, Thrombus Retriever · 89d
Cleared Mar 12, 2019
AirRay Subdural Cortical Electrodes
K183437 · Cortec GmbH
GYC · Electrode, Cortical · 90d
Cleared Mar 08, 2019
Nitinol Thermocouple (TCN) Electrode
K183177 · Boston Scientific Corporation
GXI · Probe, Radiofrequency Lesion · 112d
Cleared Mar 08, 2019
Brainsway Deep TMS System
K183303 · Brainsway , Ltd.
QCI · Transcranial Magnetic Stimulation System For Obsessive-compulsive Disorder · 101d
Cleared Mar 08, 2019
Rulo Radiofrequency Lesion Probe
K190256 · Epimed International, Inc.
GXI · Probe, Radiofrequency Lesion · 29d
Cleared Mar 07, 2019
Cervella
K182311 · Innovative Neurological Devices, LLC
QJQ · Cranial Electrotherapy Stimulator To Treat Insomnia And/or Anxiety · 195d
Cleared Mar 06, 2019
Solitaire 2 Revascularization Device, Solitaire Platinum Revascularization Device (Solitaire Revascularization Device)
K181807 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
POL · Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment · 243d
Cleared Mar 06, 2019
Visualase Thermal Therapy System
K181859 · Medtronic Navigation, Inc.
LLZ · System, Image Processing, Radiological · 237d
Cleared Feb 27, 2019
PAT (Pain Alleviation Technologies)
K182267 · Marchan Medical, LLC
NUH · Stimulator, Nerve, Transcutaneous, Over-the-counter · 190d
Cleared Feb 26, 2019
Tyece OTC EMS System
K183454 · Tyece , Ltd.
NGX · Stimulator, Muscle, Powered, For Muscle Conditioning · 75d
Cleared Feb 25, 2019
SpringTMS
K182976 · Eneura, Inc.
OKP · Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache · 122d
Cleared Feb 22, 2019
The EPAD 2 System
K182542 · Safeop Surgical, Inc.
GWF · Stimulator, Electrical, Evoked Response · 158d
Cleared Feb 19, 2019
BrainScope TBI (Model: Ahead 400)
K183241 · Brainscope Company, Inc.
PIW · Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid · 90d
Cleared Feb 17, 2019
TMS-Cobot TS MV
K182768 · Axilum Robotics
QFF · Electromechanical Arm For A Transcranial Magnetic Stimulation System · 142d
Cleared Feb 07, 2019
ROSA ONE Brain Application
K182417 · Medtech S.A
HAW · Neurological Stereotaxic Instrument · 155d
Cleared Jan 29, 2019
Solitaire 4 Revascularization Device
K183022 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
POL · Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment · 89d
Cleared Jan 29, 2019
ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010
K183070 · Asahi Intecc Co., Ltd.
MOF · Guide, Wire, Catheter, Neurovasculature · 85d
Cleared Jan 20, 2019
Codman Disposable Perforators
K183581 · Integra Lifesciences Corp.
HBF · Drills, Burrs, Trephines & Accessories (compound, Powered) · 30d
Cleared Jan 19, 2019
ELAN 4 Tools
K182527 · Aesculap, Inc.
HBE · Drills, Burrs, Trephines & Accessories (simple, Powered) · 127d
Cleared Jan 18, 2019
Aurora Surgiscope System
K182211 · Rebound Therapeutics Corporation
GWG · Endoscope, Neurological · 156d
Cleared Jan 17, 2019
DL Self-adhesive Electrode
K182111 · Shaoxing DL Healthcare Co., Ltd.
GXY · Electrode, Cutaneous · 164d
Cleared Jan 17, 2019
Esprit Nova
K182227 · Neurozone Msh Incorporated
OLZ · Automatic Event Detection Software For Polysomnograph With Electroencephalograph · 154d
Cleared Jan 11, 2019
CereLink ICP Monitor, CereLink ICP Extension Cable
K183406 · Integra Lifesciences Corp.
GWM · Device, Monitoring, Intracranial Pressure · 32d
Cleared Jan 10, 2019
Maxpower Relief
K182120 · Omron Healthcare, Inc.
NUH · Stimulator, Nerve, Transcutaneous, Over-the-counter · 157d

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All categories 4706 HAW Neurological Stereotaxic Instrument 341 GXY Electrode, Cutaneous 302 GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief 275 JXG Shunt, Central Nervous System And Components 221 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 99 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