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
4716 Neurology devices
1951–1975 of 4716
Cleared Nov 14, 2014
NUVASIVE NVM5 SYSTEM
K141968 · Nuvasive, Inc.
PDQ · Neurosurgical Nerve Locator · 116d
Cleared Nov 14, 2014
MINOP Disposable Introducer 26F
K142315 · Aesculap, Inc.
GWG · Endoscope, Neurological · 87d
Cleared Nov 13, 2014
Barricade Embolization Coil System
K142513 · Blockade Medical
HCG · Device, Neurovascular Embolization · 66d
Cleared Nov 12, 2014
HEALTH EXPERT ELCTRONIC STIMULATOR
K133929 · Shenzhen Osto Technology Company Limited
NUH · Stimulator, Nerve, Transcutaneous, Over-the-counter · 324d
Cleared Nov 07, 2014
PANTHEON ELECTROSTIMULATOR
K133980 · Pantheon Research
BWK · Stimulator, Electro-acupuncture · 315d
Cleared Nov 07, 2014
INNOVASIS CRANIAL SYSTEM
K141644 · Innovasis, Inc.
GWO · Plate, Cranioplasty, Preformed, Alterable · 141d
Not Cleared Nov 07, 2014
ZAP-IT!
DEN100024 · Ecobrands , Ltd.
OSG · Piezo-electric Stimulator For Relief Of Mosquito Bite Itch · 1520d
Not Cleared Nov 07, 2014
ZANZA-CLICK
DEN130019 · Tecnimed S.R.L.
OSG · Piezo-electric Stimulator For Relief Of Mosquito Bite Itch · 617d
Cleared Nov 05, 2014
E-Shield Multi-paried Subdermal Needle Electrodes
K142470 · Neuroinvent, Inc.
GXZ · Electrode, Needle · 63d
Cleared Oct 22, 2014
SOLITAIRE 2 REVASCULARIZATION DEVICE
K141491 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
NRY · Catheter, Thrombus Retriever · 139d
Cleared Oct 15, 2014
DANA
K141865 · Anthrotronix, Inc.
LQD · Recorder, Attention Task Performance · 97d
Cleared Oct 10, 2014
FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM
K141399 · Stimwave Technologies Incorporated
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 135d
Cleared Oct 10, 2014
QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KIT
K141869 · Hemedex Incorporated
GWM · Device, Monitoring, Intracranial Pressure · 91d
Cleared Oct 06, 2014
STARBAND, STARLIGHT
K141842 · Orthomerica Products, Inc.
MVA · Orthosis, Cranial · 90d
Cleared Oct 03, 2014
CRANIOPLUG
K140309 · Ossdsign AB
GXR · Cover, Burr Hole · 238d
Cleared Oct 03, 2014
SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETER
K141139 · Zoll Circulation
NCX · System, Hypothermia, Intravenous, Cooling · 154d
Cleared Oct 02, 2014
Electro Auricular Device
K140530 · Navigant Consulting, Inc.
BWK · Stimulator, Electro-acupuncture · 212d
Cleared Sep 26, 2014
MEDLINE NEURO SPONGE
K140369 · Medline Industries, Inc.
HBA · Neurosurgical Paddie · 224d
Cleared Sep 25, 2014
PHANTOM XL INSULATED DILATORS
K140088 · Tedan Surgical Innovations, LLC
PDQ · Neurosurgical Nerve Locator · 254d
Cleared Sep 17, 2014
ELECTRONIC PULSE STIMULATOR
K141260 · Shenzhen Jingkehui Electronic Co.., Ltd.
NUH · Stimulator, Nerve, Transcutaneous, Over-the-counter · 125d
Cleared Sep 04, 2014
HFD100 ROCKER ARM ACCESSORY
K141950 · Imris, Inc.
HBL · Holder, Head, Neurosurgical (skull Clamp) · 48d
Cleared Aug 28, 2014
EASYSTIM TN28_OTC
K140168 · Easymed Instruments Co., Ltd.
NUH · Stimulator, Nerve, Transcutaneous, Over-the-counter · 217d
Cleared Aug 26, 2014
TENS
K133979 · Sunmas (H.K.) Trading Limited
NUH · Stimulator, Nerve, Transcutaneous, Over-the-counter · 243d
Cleared Aug 22, 2014
PERSONAL KINETIGRAPH (PKG) SYSTEM
K140086 · Gkc Manufacturing Pty, Ltd.
GYD · Transducer, Tremor · 220d
Cleared Aug 22, 2014
ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III PRO HEARING SCREENER WITHOUT BARCODE SCANNER,
K141446 · Natus Medical Incorporated
GWJ · Stimulator, Auditory, Evoked Response · 81d

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All categories 4716 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