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
1126–1150 of 6334
Cleared Aug 12, 2020
SOMNOscreen plus
K201054 · Somnomedics GmbH
OLV · Standard Polysomnograph With Electroencephalograph · 113d
Cleared Aug 09, 2020
MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system
K193006 · Tonica Elektronik A/S
QCI · Transcranial Magnetic Stimulation System For Obsessive-compulsive Disorder · 286d
Cleared Aug 06, 2020
Anchor Dual Lumen Guidewire Catheter
K201076 · Aqure Medical, Inc.
QJP · Catheter, Percutaneous, Neurovasculature · 106d
Cleared Jul 31, 2020
BEAR and BEAR mini
K200803 · Foreo, Inc.
NFO · Stimulator, Transcutaneous Electrical, Aesthetic Purposes · 126d
Cleared Jul 29, 2020
Zoom 14 Guidewire
K201760 · Scientia Vascular, LLC
DQX · Wire, Guide, Catheter · 30d
Cleared Jul 21, 2020
BOBBY Balloon Guide Catheter
K193607 · MicroVention, Inc.
DQY · Catheter, Percutaneous · 208d
Cleared Jul 21, 2020
Wiggins Medical Surgical Instruments
K200383 · Wiggins Medical
HAE · Rongeur, Manual · 154d
Cleared Jul 21, 2020
Ace Medical Surgical Instruments
K200387 · Ace Medical
HAE · Rongeur, Manual · 154d
Cleared Jul 21, 2020
Riptide Aspiration System
K201689 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
NRY · Catheter, Thrombus Retriever · 29d
Cleared Jul 21, 2020
Mirage Hydrophilic Guidewire
K201690 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
DQX · Wire, Guide, Catheter · 29d
Cleared Jul 20, 2020
CERENOVUS Large Bore Catheter
K193380 · Codman & Shurtleff, Inc.
NRY · Catheter, Thrombus Retriever · 228d
Cleared Jul 15, 2020
Nalu Neurostimulation SCS system
K201618 · Boston Scientific Neuromodulation
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 30d
Cleared Jul 14, 2020
EMBOTRAP III Revascularization Device
K193063 · Neuravi, Ltd.
NRY · Catheter, Thrombus Retriever · 253d
Cleared Jul 10, 2020
ExcelsiusGPS Cranial 1.0 Module
K200047 · Globus Medical, Inc.
OLO · Orthopedic Stereotaxic Instrument · 183d
Cleared Jul 10, 2020
Infrascanner
K200203 · Infrascan, Inc.
OPT · Infrared Hematoma Detector · 164d
Cleared Jul 02, 2020
Traxcess 7 Mini Guidewire
K201487 · MicroVention, Inc.
MOF · Guide, Wire, Catheter, Neurovasculature · 28d
Cleared Jul 01, 2020
StimPlus Patch, StimPlus Patch, StimPlus Patch
K200561 · Jkh Health Co., Ltd.
NUH · Stimulator, Nerve, Transcutaneous, Over-the-counter · 119d
Cleared Jun 29, 2020
Electronic stimulator
K200354 · Shenzhen Dongjilian Electronics Co., Ltd.
NUH · Stimulator, Nerve, Transcutaneous, Over-the-counter · 137d
Cleared Jun 23, 2020
CUSA Clarity Ultrasonic Surgical Aspirator System
K200774 · Integra LifeSciences Corporation
LFL · Instrument, Ultrasonic Surgical · 90d
Cleared Jun 22, 2020
Byteflies Kit
K192549 · Byteflies NV
OMC · Reduced- Montage Standard Electroencephalograph · 279d
Cleared Jun 19, 2020
EksoNR
K200574 · Ekso Bionics, Inc.
PHL · Powered Exoskeleton · 106d
Cleared Jun 18, 2020
TENS and Muscle Stimulator
K200727 · Shenzhen Astec Technology Co., Ltd.
NUH · Stimulator, Nerve, Transcutaneous, Over-the-counter · 90d
Not Cleared Jun 15, 2020
EndeavorRx
DEN200026 · Akili Interactive Labs, Inc.
QFT · Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder · 60d
Cleared Jun 12, 2020
Electrical Stimulator System
K192201 · Gymmax Technology Shenzen Co., Ltd.
NUH · Stimulator, Nerve, Transcutaneous, Over-the-counter · 304d
Cleared Jun 11, 2020
Benchmark BMX96 Access System
K201271 · Penumbra, Inc.
DQY · Catheter, Percutaneous · 30d

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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