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
1951–1975 of 6334
Cleared Mar 23, 2015
BioniCare Hand System
K142236 · Vision Quest Industries, Inc.
NYN · Stimulator, Electrical, Transcutaneous, For Arthritis · 222d
Cleared Mar 20, 2015
DISPOSABLE PASSIVE ACCESSORY FOR MEDTRONIC StealthStation System
K142344 · Izi Medical Products, LLC
HAW · Neurological Stereotaxic Instrument · 210d
Cleared Mar 18, 2015
Penumbra Smart Coil
K143218 · Penumbra, Inc.
HCG · Device, Neurovascular Embolization · 128d
Cleared Mar 16, 2015
EASYDRILL AUTOSTOP CRANIAL PERFORATOR
K141455 · Micromar Ind. Com. , Ltd.
HBF · Drills, Burrs, Trephines & Accessories (compound, Powered) · 287d
Cleared Mar 16, 2015
Sleepware G3
K142988 · Respironics, Inc.
OLZ · Automatic Event Detection Software For Polysomnograph With Electroencephalograph · 151d
Cleared Mar 05, 2015
Nerve Monitoring Cable System
K142438 · Pioneer Surgical Technology, Inc. (Rti Surgical, Inc.)
PDQ · Neurosurgical Nerve Locator · 188d
Cleared Mar 04, 2015
NIHON KOHDEN AE-918P NEURO UNIT
K130238 · Nihon Kohden Corp.
OMA · Amplitude-integrated Electroencephalograph · 762d
Cleared Mar 04, 2015
DOLPHIN NEUROSTIM OTC
K133789 · Acumed Medical , Ltd.
NUH · Stimulator, Nerve, Transcutaneous, Over-the-counter · 447d
Cleared Feb 27, 2015
ALLIANCE SPINE RAAS CRANIAL PLATING SYSTEM
K141123 · Alliance Partners, LLC
GWO · Plate, Cranioplasty, Preformed, Alterable · 302d
Cleared Feb 27, 2015
V-GUIDE FOR VENTRICULOSTOMIES
K141559 · Arc Surgical, LLC
HAW · Neurological Stereotaxic Instrument · 260d
Cleared Feb 20, 2015
StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User Kit
K142432 · Bioness, Inc.
GZF · Stimulator, Peripheral Nerve, Implanted (pain Relief) · 175d
Cleared Feb 19, 2015
Codman Certas Plus Programmable Valve
K143111 · Medos International SARL
JXG · Shunt, Central Nervous System And Components · 113d
Cleared Feb 18, 2015
Polysmith Sleep System
K142774 · Neurotronics, Inc.
OLV · Standard Polysomnograph With Electroencephalograph · 145d
Cleared Feb 13, 2015
COGNISION EEG/EP SYSTEM
K141316 · Neuronetrix Solutions
OLT · Non-normalizing Quantitative Electroencephalograph Software · 269d
Cleared Feb 13, 2015
GALILEO NT
K142064 · Eb Neuro S.P.A.
OLT · Non-normalizing Quantitative Electroencephalograph Software · 198d
Cleared Feb 10, 2015
OPTIMUS NEURO SYSTEM
K141911 · Osteonic Co., Ltd.
GWO · Plate, Cranioplasty, Preformed, Alterable · 210d
Cleared Feb 05, 2015
MINDFRAME CAPTURE LP REVASCULARIZATION DEVICE
K141516 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
NRY · Catheter, Thrombus Retriever · 241d
Cleared Feb 03, 2015
BWMINI EEG, BWMINIHST, BWMINI PSG
K131335 · Neurovirtual USA, Inc.
GWQ · Full-montage Standard Electroencephalograph · 635d
Cleared Jan 30, 2015
ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI 008, ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI BLACK, ASAHI NEUROVASCULAR
K141751 · Asahi Intecc Co., Ltd.
MOF · Guide, Wire, Catheter, Neurovasculature · 214d
Cleared Jan 23, 2015
Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2, Cannulated PediGuard Needle 120mm, Cannulated PediGuard Handle
K143159 · Spineguard S.A.
PDQ · Neurosurgical Nerve Locator · 81d
Cleared Jan 21, 2015
Myoscience iovera system
K142866 · Myoscience, Inc.
GXH · Device, Surgical, Cryogenic · 112d
Cleared Jan 20, 2015
Zmachine
K142825 · Consolidated Research of Richmond, Inc.
OLZ · Automatic Event Detection Software For Polysomnograph With Electroencephalograph · 112d
Cleared Jan 16, 2015
COLLAGEN DURA MEMBRANE
K141608 · Collagen Matrix, Inc.
GXQ · Dura Substitute · 214d
Cleared Jan 14, 2015
Medical Monofilament Sensory Screening Toool
K143068 · Medical Monofilament Manufacturing
GXB · Esthesiometer · 82d
Cleared Jan 06, 2015
INTEGRA FLOW REGULATING VALVE SYSTEMS OSV II MODELS AND INTEGRA FLOW REGULATING VALVE LOW FLOW MODELS
K140722 · Integra LifeSciences Corporation
JXG · Shunt, Central Nervous System And Components · 291d

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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