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
4730 Neurology devices
2676–2700 of 4730
Cleared Jan 04, 2007
GEMORE REUSEABLE SELF ADHESIVE ELECTRODE, MODELS WIRE SERIES, SNAP SERIES AND DOUBLE SIDE SERIES
K062675 · Gemore Technology Co, Ltd.
GXY · Electrode, Cutaneous · 118d
Cleared Jan 03, 2007
LIFECELL DURAL SUBSTITUTE MATRIX
K061208 · Lifecell Corp.
GXQ · Dura Substitute · 247d
Cleared Dec 22, 2006
BWII EEG DIGITAL, MODEL PV 1652
K062533 · Neurovirtual USA, Inc.
OLT · Non-normalizing Quantitative Electroencephalograph Software · 115d
Cleared Dec 22, 2006
SUBDERMAL WIRE ELECTRODE, MODEL SWE
K062880 · Ives Eeg Solutions, Inc.
GXZ · Electrode, Needle · 87d
Cleared Dec 22, 2006
O&P BIVALVE CRANIAL MOLDING HELMET
K063395 · Orthotic & Prosthetic Lab, Inc.
MVA · Orthosis, Cranial · 43d
Cleared Dec 19, 2006
SUNSPOTS PRE-GELLED SURFACE ELECTRODES
K062198 · Axon Systems, Inc.
GXY · Electrode, Cutaneous · 140d
Cleared Dec 15, 2006
PIPELINE II ACCESS SYSTEM
K062814 · Depuy Spine, Inc.
GZT · Retractor, Self-retaining, For Neurosurgery · 86d
Cleared Dec 14, 2006
STRYKER NAVIGATION SYSTEM - CRANIAL MODULE, MODEL 6000-650-000
K062640 · Stryker Instruments
HAW · Neurological Stereotaxic Instrument · 99d
Cleared Dec 13, 2006
BIS BILATERAL SENSOR
K062692 · Aspect Medical Systems, Inc.
GXY · Electrode, Cutaneous · 93d
Cleared Dec 12, 2006
VECTORVISION HIP SR
K063028 · Brainlab AG
HAW · Neurological Stereotaxic Instrument · 71d
Cleared Dec 12, 2006
TRIPOLE 8C AND 16C AND EXCLAIM 8 LAMITRODE SERIES LEADS
K063080 · Advanced Neuromodulation Systems
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 63d
Cleared Dec 11, 2006
M-BOLUS EMBOLIC MICROSPHERES
K052509 · Scion Cardio-Vascular, Inc.
HCG · Device, Neurovascular Embolization · 454d
Cleared Dec 11, 2006
WICK ELECTRODE, MODEL M019260
K063402 · Intelligent Hearing Systems
GXY · Electrode, Cutaneous · 32d
Cleared Dec 07, 2006
THE TRUFILL DCS DETACHABLE COIL SYSTEM
K063254 · Cordis Neurovascular, Inc.
HCG · Device, Neurovascular Embolization · 41d
Cleared Dec 05, 2006
NEUROWAVE MICRO-INFUSION SYSTEM
K062508 · Ekos Corp.
NUI · Ultrasound, Infusion, System · 99d
Cleared Dec 04, 2006
BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
K062819 · Bioplate, Inc.
GXN · Plate, Cranioplasty, Preformed, Non-alterable · 75d
Cleared Dec 04, 2006
TWIST DRILL
K062842 · Walter Lorenz Surgical, Inc.
HBE · Drills, Burrs, Trephines & Accessories (simple, Powered) · 73d
Cleared Nov 22, 2006
KLS MARTIN QUICK DISC
K062857 · KLS-Martin L.P.
GXN · Plate, Cranioplasty, Preformed, Non-alterable · 58d
Cleared Nov 21, 2006
AESCULAP PNEUMATIC KERRISON
K062413 · Aesculap, Inc.
HAD · Rongeur, Powered · 96d
Cleared Nov 21, 2006
SMITH & NEPHEW RF CANNULAE
K063467 · Smith & Nephew, Inc.
GXI · Probe, Radiofrequency Lesion · 28d
Cleared Nov 08, 2006
ZIMMER HIP COMPUTER ASSISTED SOLUTIONS ELECTROMAGNETIC AND IMAGELESS INSTRUMENTATION
K062228 · Zimmer, Inc.
HAW · Neurological Stereotaxic Instrument · 98d
Cleared Nov 07, 2006
HEPASPHERE MICROSPHERES
K052742 · Biosphere Medical, Inc.
KRD · Device, Vascular, For Promoting Embolization · 403d
Cleared Nov 06, 2006
NICOLETONE SYSTEM V32 AMPLIFIER
K061908 · Viasys Neuro Care
GWQ · Full-montage Standard Electroencephalograph · 124d
Cleared Nov 03, 2006
MODIFICATION TO DUREPAIR DURA REGENERATION MATRIX
K063117 · Medtronic Neurosurgery
GXQ · Dura Substitute · 22d
Cleared Oct 31, 2006
MAGPRO, MODEL R30
K061645 · Tonica Elektronik A/S
GWF · Stimulator, Electrical, Evoked Response · 141d

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All categories 4730 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