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
1326–1350 of 4706
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
Cleared Dec 19, 2018
Modified BrainScope One
K181785 · Brainscope Company, Inc.
PIW · Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid · 169d
Cleared Dec 18, 2018
NuFACE FIX Skin Toning Device
K182424 · Carol Cole Company Dba Nuface
NFO · Stimulator, Transcutaneous Electrical, Aesthetic Purposes · 103d
Cleared Dec 18, 2018
Riptide Aspiration System (Riptide Large Bore Aspiration System)
K183185 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
NRY · Catheter, Thrombus Retriever · 29d
Cleared Dec 14, 2018
Honda Walking Assist Device
K181294 · Honda Motor Company, Ltd.
PHL · Powered Exoskeleton · 212d
Cleared Dec 10, 2018
reSET-O
K173681 · Pear Therapeutics, Inc.
PWE · Computerized Behavioral Therapy Device For Substance Use Disorders · 374d
Cleared Dec 10, 2018
Route 92 Medical Delivery Catheter
K182512 · Route 92 Medical, Inc.
DQY · Catheter, Percutaneous · 89d
Cleared Dec 07, 2018
Neck Care Therapy, Model: SYK 509B
K172897 · Shenzhen Osto Technology Co., Ltd.
NUH · Stimulator, Nerve, Transcutaneous, Over-the-counter · 441d
Cleared Dec 04, 2018
Spartan eCoil System
K180653 · Spartan Micro, Inc.
HCG · Device, Neurovascular Embolization · 266d
Cleared Nov 29, 2018
Persyst 14 EEG Review and Analysis Software
K182181 · Persyst Development Corporation
OMB · Automatic Event Detection Software For Full-montage Electroencephalograph · 108d
Cleared Nov 29, 2018
Espire Elbow Pro, Espire Elbow Hybrid
K182757 · College Park Industries, Inc.
GXY · Electrode, Cutaneous · 62d
Cleared Nov 27, 2018
gammaCore Sapphire
K182369 · Electrocore, Inc.
PKR · Non-invasive Vagus Nerve Stimulator - Headache · 88d
Cleared Nov 26, 2018
Low-frequency Multi-function physiotherapy instrument
K172837 · Shenzhen Osto Technology Co., Ltd.
NUH · Stimulator, Nerve, Transcutaneous, Over-the-counter · 433d
Cleared Nov 23, 2018
Visor System
K182967 · Cerebrotech Medical Systems, Inc.
QAF · Impedance Plethysmograph, Cranial · 28d
Cleared Nov 21, 2018
PlayMakar Sport Muscle Stimulator, Model PRO-500
K182581 · Playmakar, Inc.
NUH · Stimulator, Nerve, Transcutaneous, Over-the-counter · 63d
Cleared Nov 20, 2018
MR Compatible Aspiration Kit
K181731 · Mri Interventions, Inc.
GWG · Endoscope, Neurological · 144d
Cleared Nov 20, 2018
CodMan Certas Plus Programmable Valve
K182265 · Integra Lifesciences Corp.
JXG · Shunt, Central Nervous System And Components · 91d
Cleared Nov 16, 2018
Serenity Piezo Sensor, Serenity Thermocouple Sensor
K181709 · Neurotronics, Inc.
OLV · Standard Polysomnograph With Electroencephalograph · 141d
Cleared Nov 14, 2018
React 71 Catheter
K182097 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
DQY · Catheter, Percutaneous · 103d
Cleared Nov 14, 2018
Riptide Aspiration System (React 71 Catheter)
K182101 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
NRY · Catheter, Thrombus Retriever · 103d

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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