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
4751 Neurology devices
3601–3625 of 4751
Cleared Jan 21, 1998
STEALTHSTATION SYSTEM
K974187 · Surgical Navigation Technologies, Inc.
HAW · Neurological Stereotaxic Instrument · 131d
Cleared Jan 16, 1998
EMBLA
K971813 · Ferguson Medical
OLV · Standard Polysomnograph With Electroencephalograph · 245d
Cleared Jan 16, 1998
AESCULAP CRANIOFIX TITANIUM CLAMP SYSTEM
K972332 · Aesculap, Inc.
GXN · Plate, Cranioplasty, Preformed, Non-alterable · 207d
Cleared Jan 16, 1998
SERVOTRONIC EC100 SYSTEM
K972857 · Medicon EG
HBC · Motor, Drill, Electric · 168d
Cleared Jan 16, 1998
ADVANTAGE EMG SYSTEM, MODEL #A100
K974010 · Advantage Medical Division of Cme Telemetrix
IKN · Electromyograph, Diagnostic · 87d
Cleared Jan 09, 1998
CODMAN INTRACRANIAL BOLT
K974088 · Johnson & Johnson Professionals, Inc.
GWM · Device, Monitoring, Intracranial Pressure · 71d
Cleared Dec 29, 1997
CODMAN HAKIM MICRO PRECISION VALVE
K973774 · Johnson & Johnson Professionals, Inc.
JXG · Shunt, Central Nervous System And Components · 87d
Cleared Dec 24, 1997
DURA-GUARD-DURAL REPAIR PATCH
K973706 · Bio-Vascular, Inc.
GXQ · Dura Substitute · 86d
Cleared Dec 17, 1997
PATHWAY ELECTROMYOGRAPH
K973537 · The Prometheus Group
HCC · Device, Biofeedback · 90d
Cleared Dec 16, 1997
MAURICE WORLDWIDE SHUNT SYSTEM
K973525 · Integra Neurocare, LLC
JXG · Shunt, Central Nervous System And Components · 90d
Cleared Dec 09, 1997
LYOPLANT DURA SUBSTITUTE(VARIOUS)
K970851 · Aesculap, Inc.
GXQ · Dura Substitute · 277d
Cleared Dec 09, 1997
ULTRACELL NEURO SPONGES
K973083 · Ultracell Medical Technologies, Inc.
HBA · Neurosurgical Paddie · 113d
Cleared Dec 05, 1997
ADVANTAGE 3000
K973355 · Advantage Medical Division of Cme Telemetrix
IKN · Electromyograph, Diagnostic · 88d
Cleared Dec 01, 1997
MEDI-DX 7000
K964622 · Neuro-Diagnostic Assoc.
LLN · Device, Vibration Threshold Measurement · 378d
Cleared Nov 26, 1997
YASARGIL TITANIUM ANEURYSM CLIPS (FTXXXT)
K970050 · Aesculap, Inc.
HCH · Clip, Aneurysm · 324d
Cleared Nov 21, 1997
STEALTHSTATION SYSTEM
K974161 · Surgical Navigation Technologies, Inc.
HAW · Neurological Stereotaxic Instrument · 86d
Cleared Nov 20, 1997
CTF SYSTEMS INC, WHOLE-CORTEX MEG SYSTEM (WITH OPTIONAL EEG SUBSYSTEM)
K971329 · Ctf Systems, Inc.
GWQ · Full-montage Standard Electroencephalograph · 224d
Cleared Nov 20, 1997
EPOCH 2000 NEUROLOGICAL WORKSTATION
K971819 · Axon Systems, Inc.
GWF · Stimulator, Electrical, Evoked Response · 188d
Cleared Nov 20, 1997
TECA DISPOSABLE MONOPOLAR NEEDLE ELECTRODES
K973442 · Medelec, Inc. D.B.A. Teca Corp.
IKT · Electrode, Needle, Diagnostic Electromyograph · 70d
Cleared Nov 20, 1997
TECA MYOJECT DISPOSABLE NEEDLE ELECTRODES
K973444 · Medelec, Inc. D.B.A. Teca Corp.
IKT · Electrode, Needle, Diagnostic Electromyograph · 70d
Cleared Nov 20, 1997
NEUROLINE, DISPOSABLE CONCENTRIC NEEDLE ELECTRODES
K973529 · Medicotest A/S
IKT · Electrode, Needle, Diagnostic Electromyograph · 63d
Cleared Nov 17, 1997
CAROLINE GUIDE/DELIA LOCALIZER
K973277 · Surgical Solutions, Inc.
HAW · Neurological Stereotaxic Instrument · 76d
Cleared Nov 03, 1997
EXTERNAL CSF DRAINAGE MANAGEMENT SYSTEMS
K972994 · Integra Neurocare, LLC
JXG · Shunt, Central Nervous System And Components · 83d
Cleared Oct 29, 1997
NEUROLOGICAL ENDOSCOPE
K970162 · Richard Wolf Medical Instruments Corp.
GWG · Endoscope, Neurological · 286d
Cleared Oct 08, 1997
DISSECTRON PORTABLE UNIT
K972612 · Satelec
LBK · Neurosurgical Ultrasonic Instruments · 86d

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All categories 4751 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