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
4720 Neurology devices
2076–2100 of 4720
Cleared Oct 18, 2013
CRANIAL MAP NEURO
K131214 · Stryker Corporate
HAW · Neurological Stereotaxic Instrument · 172d
Cleared Oct 17, 2013
UNIVERSAL NEURO 3 SYSTEM
K131775 · Stryker
GWO · Plate, Cranioplasty, Preformed, Alterable · 122d
Cleared Oct 10, 2013
BARRICADE EMBOLIZATION COIL SYSTEM
K132482 · Blockade Medical
HCG · Device, Neurovascular Embolization · 63d
Cleared Oct 08, 2013
BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT
K131015 · Cook Biotech, Inc.
GXQ · Dura Substitute · 180d
Cleared Oct 04, 2013
MICROPLEX COIL SYSTEM (MCS)
K131948 · MicroVention, Inc.
HCG · Device, Neurovascular Embolization · 99d
Cleared Oct 01, 2013
TRINITY ELE
K131251 · Carol Cole Company
NFO · Stimulator, Transcutaneous Electrical, Aesthetic Purposes · 153d
Cleared Sep 30, 2013
CRANIAL LOOP, CRANIAL LOOP L AND CRANIAL LOOP XL AND CRANIAL BONE FIXATION SYSTEM
K132044 · Neos Surgery S.L
GXR · Cover, Burr Hole · 90d
Cleared Sep 27, 2013
STRYKER NAV3I PLATFORM
K130874 · Stryker Corporate
HAW · Neurological Stereotaxic Instrument · 182d
Cleared Sep 26, 2013
TCM MASSAGER
K130150 · Anhui Jinjianqiao Med-Tech Co,. , Ltd.
NUH · Stimulator, Nerve, Transcutaneous, Over-the-counter · 247d
Cleared Sep 20, 2013
MICROPLEX COIL SYSTEM (MCS), VFC
K132317 · MicroVention, Inc.
HCG · Device, Neurovascular Embolization · 57d
Cleared Sep 17, 2013
FACIAL SPA
K122711 · Nuskin
NFO · Stimulator, Transcutaneous Electrical, Aesthetic Purposes · 378d
Cleared Sep 16, 2013
OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060)
K130802 · Shenzhen Dongdixin Technology Co., Ltd.
NUH · Stimulator, Nerve, Transcutaneous, Over-the-counter · 178d
Cleared Sep 13, 2013
TANYX
K123866 · Medecell Us, Inc.
NUH · Stimulator, Nerve, Transcutaneous, Over-the-counter · 270d
Cleared Sep 13, 2013
PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S)
K123902 · Oktx, LLC
IKN · Electromyograph, Diagnostic · 269d
Cleared Sep 06, 2013
EYESEECAM VHIT
K131681 · Interacoustics A/S
GWN · Nystagmograph · 88d
Cleared Sep 05, 2013
SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEM
K123723 · Synthes
GWO · Plate, Cranioplasty, Preformed, Alterable · 275d
Cleared Aug 30, 2013
INTEGRA LICOX PTO2 MONITOR
K131184 · Integra Lifesciences Corp.
GWM · Device, Monitoring, Intracranial Pressure · 127d
Cleared Aug 23, 2013
MAGSTIM DOUBLE 70-2 COIL
K130403 · The Magstim Company , Ltd.
GWF · Stimulator, Electrical, Evoked Response · 185d
Cleared Aug 16, 2013
SMARTFLOW CATHETER
K123605 · Mri Interventions, Inc.
HCA · Catheter, Ventricular · 268d
Cleared Aug 16, 2013
TRS CRANIAL BONE VOID FILLER(TRS C-BVF)
K123633 · Tissue Regeneration Systems, Inc.
GXR · Cover, Burr Hole · 266d
Cleared Aug 16, 2013
JIAJIAN CMN STIMULATOR
K130768 · Wuxi Jiajian Medical Instrument Co., Ltd.
BWK · Stimulator, Electro-acupuncture · 149d
Cleared Aug 09, 2013
LIVE VIEW PANEL (LVP)
K131415 · Neurotronics, Inc.
OLV · Standard Polysomnograph With Electroencephalograph · 85d
Cleared Aug 08, 2013
PEDIGUARD NERVE DETECTOR SYSTEM
K123390 · Spineguard S.A.
PDQ · Neurosurgical Nerve Locator · 279d
Cleared Aug 07, 2013
QUADCUT
K130608 · Medtronic Navigation, Inc.
HAW · Neurological Stereotaxic Instrument · 153d
Cleared Aug 05, 2013
SYMMETRY KERRISON DISPOSABLE TIP RONGEURS
K130541 · Symmetry Surgical
HAE · Rongeur, Manual · 157d

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All categories 4720 HAW Neurological Stereotaxic Instrument 341 GXY Electrode, Cutaneous 306 GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief 276 JXG Shunt, Central Nervous System And Components 222 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 100 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