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
4715 Neurology devices
1851–1875 of 4715
Cleared Aug 12, 2015
PERSYST 13 (P13) EEG REVIEW AND ANALYSIS SOFTWARE
K151929 · Persyst Development Corporation
OMB · Automatic Event Detection Software For Full-montage Electroencephalograph · 29d
Cleared Aug 06, 2015
Penumbra System 110 Aspiration Tubing
K151623 · Penumbra, Inc.
NRY · Catheter, Thrombus Retriever · 51d
Cleared Jul 31, 2015
MagVita TMS Therapy System
K150641 · Tonica Elektronik A/S
OBP · Transcranial Magnetic Stimulator · 142d
Cleared Jul 30, 2015
Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR and DTRH
K150371 · Diros Technology, Inc.
GXI · Probe, Radiofrequency Lesion · 167d
Cleared Jul 28, 2015
Philips Self-Adhesive Electrodes
K151033 · Philips Consumer Lifestyle
GXY · Electrode, Cutaneous · 102d
Cleared Jul 28, 2015
Axium Detachable Coil System
K151447 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
HCG · Device, Neurovascular Embolization · 60d
Cleared Jul 27, 2015
QuadraSphere Microspheres
K151187 · Biosphere Medical, S.A.
KRD · Device, Vascular, For Promoting Embolization · 84d
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

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All categories 4715 HAW Neurological Stereotaxic Instrument 341 GXY Electrode, Cutaneous 305 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