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
1901–1925 of 6334
Cleared Jul 27, 2015
Barricade Embolization Coil System
K151760 · Blockade Medical
HCG · Device, Neurovascular Embolization · 28d
Cleared Jul 21, 2015
TENS AND POWERED MUSCLE STIMULATOR
K143268 · Shenzhen As-Tec Technology Co., Ltd.
NUH · Stimulator, Nerve, Transcutaneous, Over-the-counter · 250d
Cleared Jul 21, 2015
PulseRelief
K151035 · Philips Consumer Lifestyle
NUH · Stimulator, Nerve, Transcutaneous, Over-the-counter · 95d
Cleared Jul 10, 2015
Penumbra Smart Coil
K151572 · Penumbra, Inc.
HCG · Device, Neurovascular Embolization · 29d
Cleared Jul 08, 2015
NavSuite3 Kit
K150301 · Stryker Leibinger GmbH & Co. KG - Navigation
HAW · Neurological Stereotaxic Instrument · 152d
Cleared Jul 08, 2015
SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm
K151536 · Mri Interventions, Inc.
HBG · Drills, Burrs, Trephines & Accessories (manual) · 30d
Cleared Jul 06, 2015
Electronic Pulse Stimulator
K150995 · Shenzhen Jingkehui Electronic Co.., Ltd.
NUH · Stimulator, Nerve, Transcutaneous, Over-the-counter · 82d
Cleared Jul 01, 2015
STARband, STARlight
K151147 · Orthomerica Products, Inc.
OAN · Orthosis, Cranial, Laser Scan · 62d
Cleared Jun 29, 2015
Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and Tongue Depressor 90 mm
K150518 · Dupaco, Inc.
JXL · Block, Bite · 119d
Cleared Jun 24, 2015
Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Blade
K151387 · Stryker
HBW · Fastener, Plate, Cranioplasty · 29d
Cleared Jun 23, 2015
DiscoverEEG System, Model DE-401
K142834 · Neurowave Systems, Inc.
OLT · Non-normalizing Quantitative Electroencephalograph Software · 266d
Cleared Jun 19, 2015
NEURON-SPECTRUM-4/P WITH NEURON-SPECTRUM.NET SOFTWARE
K133995 · Neurosoft , Ltd.
OLT · Non-normalizing Quantitative Electroencephalograph Software · 540d
Cleared Jun 12, 2015
MICRUSFRAME 10/18, DELTAFILL 18, DELTAXSFT 10, GALAXY G3 FILL/XSFT STRETCH RESISTANT MICROCOIL DELIVERY SYSTEMS
K150319 · Codman & Shurtleff, Inc.
HCG · Device, Neurovascular Embolization · 123d
Cleared Jun 12, 2015
NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's Hook
K150378 · Nico Corporation
GZT · Retractor, Self-retaining, For Neurosurgery · 119d
Cleared Jun 12, 2015
Trevo XP ProVue Retriever (4x30mm)
K150616 · Concentric Medical, Inc.
NRY · Catheter, Thrombus Retriever · 94d
Cleared Jun 11, 2015
Synergy Cranial
K150216 · Medtronic Navigation, Inc.
HAW · Neurological Stereotaxic Instrument · 132d
Cleared Jun 05, 2015
Freedom Spinal Cord Stimulator System
K150517 · Stimwave Technologies Incorporated
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 95d
Not Cleared Jun 05, 2015
COGNIVUE
DEN130033 · Cerebral Assessment Systems, Inc.
PKQ · Computerized Cognitive Assessment Aid · 723d
Cleared Jun 03, 2015
DISPOSABLE PRE-GELLED SURFACE ELECTRODE
K142159 · Rochester Electro Medical, Inc.
GXY · Electrode, Cutaneous · 301d
Cleared Jun 02, 2015
Everyway Facial MENS
K142794 · Everyway Medical Instruments Co.,Ltd
NFO · Stimulator, Transcutaneous Electrical, Aesthetic Purposes · 246d
Cleared May 29, 2015
SmartTENS
K143430 · Easy Med Instrument Co., Ltd.
NUH · Stimulator, Nerve, Transcutaneous, Over-the-counter · 179d
Cleared May 28, 2015
ViMove
K142494 · Dorsavi, Ltd.
IKN · Electromyograph, Diagnostic · 265d
Cleared May 27, 2015
Synapse Transcutaneous Electrical Stimulation Device
K143198 · Synapse Electroceutical Limited
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 202d
Cleared May 22, 2015
Penumbra System ACE
K142458 · Penumbra, Inc.
NRY · Catheter, Thrombus Retriever · 262d
Cleared May 22, 2015
Scrambler Therapy MC-5 A Device
K142666 · Delta International Services & Logistics S.R.L
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 246d

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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