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
4749 Neurology devices
3351–3375 of 4749
Cleared Dec 22, 1999
GUGLIELMI DETACHABLE (GDC)
K991139 · Boston Scientific, Target
HCG · Device, Neurovascular Embolization · 261d
Cleared Dec 21, 1999
SNN FLUORO NAVIGATION SYSTEM
K993673 · I.S.G. Technologies, Inc.
HAW · Neurological Stereotaxic Instrument · 50d
Cleared Dec 21, 1999
MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE
K994175 · Sodemsystems
HBB · Motor, Drill, Pneumatic · 11d
Cleared Dec 17, 1999
ULTRA-GARMENT ELECTRODE
K993130 · Newwave Medical, LLC
GXY · Electrode, Cutaneous · 88d
Cleared Dec 17, 1999
EIM-107 PREP-CHECK
K993202 · General Devices
GZO · Device, Galvanic Skin Response Measurement · 84d
Cleared Dec 15, 1999
DCI ENDOSCOPE
K993539 · KARL STORZ Endoscopy-America, Inc.
GWG · Endoscope, Neurological · 57d
Cleared Dec 09, 1999
RELIEFBAND NST DEVICE MODELS WB-2,WB-6,WB-R
K983907 · Woodside Biomedical, Inc.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 401d
Cleared Dec 07, 1999
VIRTUOSO-STEREOTAXIC PLANNING SOFTWARE
K991706 · Stryker Corp.
HAW · Neurological Stereotaxic Instrument · 202d
Cleared Dec 03, 1999
BIOMAGNETIC TECHNOLOGIES MAGNES 3600 WHOLE HEAD MEG
K993708 · Biomagnetic Technologies, Inc.
OLX · Source Localization Software For Electroencephalograph Or Magnetoencephalograph · 30d
Cleared Nov 22, 1999
3D1 MICROPOSITIONING HEADSTAGE
K993501 · Scientific Tools, Inc.
HAW · Neurological Stereotaxic Instrument · 38d
Cleared Nov 19, 1999
MED-4000
K993823 · Micro Current Technology, Inc.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 7d
Cleared Nov 18, 1999
CRANIOFACIAL CALCIUM PHOSPHATE CERAMIC BONE FILLER
K990290 · Biomet, Inc.
GXP · Methyl Methacrylate For Cranioplasty · 293d
Cleared Nov 16, 1999
SABRE
K993177 · Sle Limited
GWJ · Stimulator, Auditory, Evoked Response · 85d
Cleared Nov 09, 1999
1818 TENS UNIT
K992709 · 138 Medical Supplies, Inc.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 90d
Cleared Nov 03, 1999
AXON MP-1 MICROPOSITIONER
K990683 · Axon Instruments, Inc.
HAW · Neurological Stereotaxic Instrument · 245d
Cleared Nov 03, 1999
BRAVO MULTI-MODALITY SYSTEM
K991054 · Nicolet Biomedical, Inc.
GWQ · Full-montage Standard Electroencephalograph · 218d
Cleared Nov 02, 1999
AD-TECH'S FORAMEN OVALE ELECTRODE
K990788 · Ad-Tech Medical Instrument Corp
GZL · Electrode, Depth · 237d
Cleared Nov 02, 1999
THE MAYFIELD / ACCISS SYSTEM WITH WINDOWS NT FOR CRANIAL SURGERY, THE MAYFIELD / OPTICAL ACCISS SYSTEM WITH WINDOWS NT F
K992843 · Ohio Medical Instrument Co., Inc.
HAW · Neurological Stereotaxic Instrument · 70d
Cleared Oct 25, 1999
INTERACOUSTICS EP 15 ABR STAND ALONE UNIT
K991853 · Idem (Int'L Dist. of Electronics For Medicine)
GWJ · Stimulator, Auditory, Evoked Response · 146d
Cleared Oct 25, 1999
VENTIL-A ORAL PROTECTOR
K992269 · Somatics, Inc.
JXL · Block, Bite · 111d
Cleared Oct 25, 1999
ASPIRATION/IRRIGATION CATHETER, MODEL AC-1000
K992796 · Image-Guided Neurologics, Inc.
HCA · Catheter, Ventricular · 67d
Cleared Oct 22, 1999
ACCUGUIDE MUSCLE INJECTION MONITOR
K990793 · Medtronic Xomed
GXZ · Electrode, Needle · 226d
Cleared Oct 21, 1999
THE BRIGHT MEDICAL DILATION RETRACTOR SYSTEM
K992898 · Bright Medical Instruments
GZT · Retractor, Self-retaining, For Neurosurgery · 55d
Cleared Oct 15, 1999
ACTITRAC
K992410 · Individual Monitoring Systems, Inc.
GWQ · Full-montage Standard Electroencephalograph · 87d
Cleared Oct 15, 1999
CODMAN SINGLE AND DOUBLE LUMEN SKULL BOLT KITS
K992591 · Codman & Shurtleff, Inc.
GWM · Device, Monitoring, Intracranial Pressure · 74d

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All categories 4749 HAW Neurological Stereotaxic Instrument 342 GXY Electrode, Cutaneous 307 GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief 281 JXG Shunt, Central Nervous System And Components 224 NUH Stimulator, Nerve, Transcutaneous, Over-the-counter 211 HCG Device, Neurovascular Embolization 173 GWQ Full-montage Standard Electroencephalograph 142 NRY Catheter, Thrombus Retriever 114 GZB Stimulator, Spinal-cord, Implanted (pain Relief) 113 GWF Stimulator, Electrical, Evoked Response 101 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