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
4727 Neurology devices
2476–2500 of 4727
Cleared Jul 28, 2008
ELEKTA NEUROMAG WITH MAXWELL FILTER WITH INTERNAL ACTIVE SHIELDING
K081430 · Elekta Neuromag OY
OLX · Source Localization Software For Electroencephalograph Or Magnetoencephalograph · 68d
Cleared Jul 18, 2008
PIGALILEO 4TH GENERATION SYSTEM
K080875 · Smith & Nephew, Inc.
HAW · Neurological Stereotaxic Instrument · 109d
Cleared Jul 18, 2008
CINCH ANCHOR, MODEL 1194
K081208 · Advanced Neuromodulation Systems
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 80d
Cleared Jul 17, 2008
STRYKER POWER TOOL NAVIGATOR ATTACHMENT
K080450 · Stryker Corp.
HAW · Neurological Stereotaxic Instrument · 149d
Cleared Jul 15, 2008
ULTRASHARP CONCENTRIC NEEDLES
K080914 · Rochester Electro Medical, Inc.
IKT · Electrode, Needle, Diagnostic Electromyograph · 105d
Cleared Jul 11, 2008
HYDROSOFT AND HYDROSOFT PLUS EMBOLIZATION COIL SYSTEMS
K080666 · MicroVention, Inc.
HCG · Device, Neurovascular Embolization · 123d
Cleared Jul 02, 2008
ELECTRODE ARRAY CAP
K071446 · Electrode Arrays
GXY · Electrode, Cutaneous · 405d
Cleared Jun 30, 2008
MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 STRETCH RESISTANT
K080379 · Micrus Endovascular Corporation
HCG · Device, Neurovascular Embolization · 138d
Cleared Jun 27, 2008
MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM
K071984 · Cma Microdialysis AB
GWM · Device, Monitoring, Intracranial Pressure · 344d
Cleared Jun 20, 2008
PRO TENS, MODEL WL-240 RX
K080304 · Well-Life Healthcare Limited
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 136d
Cleared Jun 13, 2008
FREMS SSC DISPOSABLE FOAM ELECTRODES, MODEL 800-000-057
K080902 · Lorenz Biotech S.P.A.
GXY · Electrode, Cutaneous · 72d
Cleared Jun 06, 2008
NERVE MONITORING CABLE
K073229 · Pioneer Surgical Technology
GXZ · Electrode, Needle · 204d
Cleared Jun 06, 2008
UNI-KNEE 2.0
K080678 · Brainlab AG
HAW · Neurological Stereotaxic Instrument · 88d
Cleared Jun 05, 2008
MERCI RETRIEVER
K081305 · Concentric Medical, Inc.
NRY · Catheter, Thrombus Retriever · 28d
Cleared May 30, 2008
COLUMBIA 600 ELECTRODE, COLUMBIA 06 LEADWIRE
K080386 · Columbia Scientific Development, LLC
GXY · Electrode, Cutaneous · 107d
Cleared May 29, 2008
OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEM
K073006 · Takiron Co., Ltd.
GWO · Plate, Cranioplasty, Preformed, Alterable · 218d
Cleared May 29, 2008
VSU - VISIONSENSE STEREOSCOPIC VISION SYSTEM
K081102 · Visionsense, Ltd.
GWG · Endoscope, Neurological · 42d
Cleared May 23, 2008
NEMUS SYSTEM
K073415 · Eb Neuro S.P.A.
IKN · Electromyograph, Diagnostic · 171d
Cleared May 23, 2008
SPINEASSIST SYSTEM
K073467 · Mazor Surgical Technologies , Ltd.
HAW · Neurological Stereotaxic Instrument · 165d
Cleared May 23, 2008
ORTHOPILOT NEXT GENERATION, MODEL FS101-FS106
K080547 · Aesculap Implant System, Inc.
HAW · Neurological Stereotaxic Instrument · 85d
Cleared May 21, 2008
ELEXOMA MEDIC
K070412 · Redplane AG
QJQ · Cranial Electrotherapy Stimulator To Treat Insomnia And/or Anxiety · 464d
Cleared May 16, 2008
SUBDERMAL NEEDLE ELECTRODES
K072276 · Xian Friendship Electronics Co., Ltd.
GXZ · Electrode, Needle · 275d
Cleared May 16, 2008
SHUNTCHECK - CSF SHUNT FLOW DETECTOR
K080168 · Neuro Diagnostic Devices
JXG · Shunt, Central Nervous System And Components · 114d
Cleared May 13, 2008
LEKSELL SURGIPLAN, MODEL 1006947
K080250 · Elekta Instrument AB
HAW · Neurological Stereotaxic Instrument · 103d
Cleared May 09, 2008
KSEA CLEARVISION II, MODEL 40334120
K072410 · KARL STORZ Endoscopy-America, Inc.
GWG · Endoscope, Neurological · 256d

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All categories 4727 HAW Neurological Stereotaxic Instrument 342 GXY Electrode, Cutaneous 307 GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief 278 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 141 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 87 NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes 74 GWM Device, Monitoring, Intracranial Pressure 71 OBP Transcranial Magnetic Stimulator 67