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

6235
Total
6180
Cleared
154d
Avg (2y)
1976
Since
1750 Neurology devices
1251–1275 of 1750
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
Cleared Jan 02, 2019
Polaris RF Ablation System
K181864 · Baylis Medical Company, Inc.
GXD · Generator, Lesion, Radiofrequency · 174d
Cleared Jan 02, 2019
ClearUP Sinus Pain Relief
K182025 · Tivic Health Systems, Inc.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 156d
Cleared Jan 02, 2019
Optimus Neuro System
K183352 · Osteonic Co., Ltd.
GWO · Plate, Cranioplasty, Preformed, Alterable · 30d
Not Cleared Dec 28, 2018
EyeBOX
DEN170091 · Oculogica, Inc.
QEA · Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid · 371d
Cleared Dec 20, 2018
Embrace
K181861 · Empatica S.R.L.
POS · Physiological Signal Based Seizure Monitoring System · 161d
Cleared Dec 20, 2018
microTargeting Guideline 4000 5.0 System
K183123 · FHC, Inc.
GZL · Electrode, Depth · 37d

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All categories 1750 NUH Stimulator, Nerve, Transcutaneous, Over-the-counter 121 HAW Neurological Stereotaxic Instrument 93 QJP Catheter, Percutaneous, Neurovasculature 91 GXY Electrode, Cutaneous 90 NRY Catheter, Thrombus Retriever 73 JXG Shunt, Central Nervous System And Components 71 GZB Stimulator, Spinal-cord, Implanted (pain Relief) 71 NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes 49 OBP Transcranial Magnetic Stimulator 48 HCG Device, Neurovascular Embolization 41 GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief 38 GWG Endoscope, Neurological 38 DQY Catheter, Percutaneous 36 MOF Guide, Wire, Catheter, Neurovasculature 29 GWQ Full-montage Standard Electroencephalograph 27