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
1901–1925 of 4715
Cleared Apr 02, 2015
POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM/POLARIS ADJUSTABLE VALVE WITH SIPHONX
K141227 · Sophysa SA
JXG · Shunt, Central Nervous System And Components · 325d
Cleared Apr 02, 2015
AESCULAP - MEITHKE PROGAV 2.0 ADJUSTABLE SHUNT SYSTEM
K141687 · Aesculap, Inc.
JXG · Shunt, Central Nervous System And Components · 294d
Cleared Apr 02, 2015
MYGAIT STIMULATION SYSTEM
K141812 · Otto Bock Healthcare Products GmbH
GZI · Stimulator, Neuromuscular, External Functional · 269d
Cleared Apr 02, 2015
BRIGHTMATTER NAVIGATION SYSTEM
K142024 · Synaptive Medical, Inc.
HAW · Neurological Stereotaxic Instrument · 251d
Cleared Mar 27, 2015
DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS)
K141385 · Depuy Synthes Companies of Johnson & Johnson
HBW · Fastener, Plate, Cranioplasty · 304d
Cleared Mar 27, 2015
NuVasive NVM5 System
K143641 · Nu Vasive, Incorporated
PDQ · Neurosurgical Nerve Locator · 95d
Cleared Mar 25, 2015
STYLET, 23CM, SKULL-MOUNT PATIENT TRACKER, NON-INVASIVE PATIENT TRACKER, TRACER POINTER, TOUCH-N-GO POINTER, NAVIGATION
K141833 · Medtronic Navigation, Inc.
HAW · Neurological Stereotaxic Instrument · 261d
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

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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