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
4745 Neurology devices
3101–3125 of 4745
Cleared May 21, 2003
SPIN DOWN RAPIDFLAP
K031034 · Walter Lorenz Surgical, Inc.
GXN · Plate, Cranioplasty, Preformed, Non-alterable · 50d
Cleared May 15, 2003
SURGISIS NERVE CUFF
K031069 · Cook Biotech, Inc.
JXI · Cuff, Nerve · 41d
Cleared May 14, 2003
CODMAN BACTISEAL BARIUM STRIPED CATHETERS
K031123 · Codman & Shurtleff, Inc.
HCA · Catheter, Ventricular · 35d
Cleared May 14, 2003
OLYMPIC CFM 6000
K031149 · Olympic Medical Corp.
OMA · Amplitude-integrated Electroencephalograph · 34d
Cleared May 14, 2003
MATRIX STRETCH RESISTANT DETACHABLE COIL
K031168 · Boston Scientific, Target
HCG · Device, Neurovascular Embolization · 30d
Cleared May 09, 2003
STACKED ABR FOR NAVIGATOR PRO
K030907 · Bio-Logic Systems Corp.
GWJ · Stimulator, Auditory, Evoked Response · 46d
Cleared May 05, 2003
BIOMET CRANIOFACIAL ACRYLIC CEMENT
K011399 · Biomet, Inc.
GXP · Methyl Methacrylate For Cranioplasty · 728d
Cleared May 02, 2003
HIVOX DREAMATE DM-800
K021952 · Hivox Biotek, Inc.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 323d
Cleared May 02, 2003
DIEGO POWERED DISSECTOR HANDPIECE WITH STARLINK IMAGE-GUIDED ADAPTER MOUNTING INTERFACE
K030343 · Gyrus Ent LLC
HAW · Neurological Stereotaxic Instrument · 88d
Cleared Apr 28, 2003
MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL (EP) SYSTEM
K031009 · Bio-Logic Systems Corp.
GWJ · Stimulator, Auditory, Evoked Response · 28d
Cleared Apr 24, 2003
A127 LEAD EXTENSION
K030461 · Advanced Neuromodulation Systems
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 71d
Cleared Apr 01, 2003
OSTEOMED CRANIAL FLAP FIXATION SYSTEM
K022277 · Osteomed Corp.
GXN · Plate, Cranioplasty, Preformed, Non-alterable · 260d
Cleared Mar 28, 2003
MODIFICATION TO AXXESS SPINAL CORD STIMULATION LEAD
K030674 · Advanced Neuromodulation Systems
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 24d
Cleared Mar 24, 2003
AESULAP KOPITNIK AVM MICROCLIPS AND APPLIER
K024349 · Aesculap, Inc.
HCH · Clip, Aneurysm · 84d
Cleared Mar 21, 2003
ENDOSCOPE SET FOR MAGNETIC RESONANCE (MR), MODELS 8767.412, 8767.121 & 8767.452
K022198 · Richard Wolf Medical Instruments Corp.
GWG · Endoscope, Neurological · 259d
Cleared Mar 20, 2003
STRYKER LEIBINGER CRANIAL FIXATION SYSTEM
K030378 · Stryker Instruments
GXN · Plate, Cranioplasty, Preformed, Non-alterable · 43d
Cleared Mar 20, 2003
AESCULAP - MIETHKE SHUNT SYSTEM W/ NPH-DSV
K030698 · Aesculap, Inc.
JXG · Shunt, Central Nervous System And Components · 14d
Cleared Mar 14, 2003
GDC STRETCH RESISTANT DETACHABLE COIL
K030475 · Boston Scientific, Target
HCG · Device, Neurovascular Embolization · 29d
Cleared Mar 12, 2003
NAVIGUS FIDUCIAL MARKER SYSTEM, MODELS FM-1000, FM-2000
K024201 · Image-Guided Neurologics, Inc.
HAW · Neurological Stereotaxic Instrument · 82d
Cleared Mar 11, 2003
RAPID PROGRAMMAR
K030118 · Advanced Neuromodulation Systems
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 57d
Cleared Feb 26, 2003
HERMETIC PLUS EXTERNAL CSF DRAINAGE SYSTEMS, INS-8301,INS-8302,INS-8700, NL850-830N
K030289 · Integra Lifesciences Corp.
JXG · Shunt, Central Nervous System And Components · 29d
Cleared Feb 25, 2003
NAVIGUS II TRAJECTORY GUIDE WITH VERIFICATION RETICULES
K023949 · Image-Guided Neurologics, Inc.
HAW · Neurological Stereotaxic Instrument · 90d
Cleared Jan 22, 2003
STRYKER NAVIGATION SYSTEM - HIP MODULE
K022365 · Stryker Instruments
HAW · Neurological Stereotaxic Instrument · 184d
Cleared Jan 13, 2003
DATEX-OHMEDA S/5 ENTROPY MODULE, M-ENTROPY AND ACCESSORIES
K023459 · Datex-Ohmeda
OLW · Index-generating Electroencephalograph Software · 90d
Cleared Jan 06, 2003
NIM-PRS
K024316 · Medtronic Xomed, Inc.
IKN · Electromyograph, Diagnostic · 11d

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All categories 4745 HAW Neurological Stereotaxic Instrument 342 GXY Electrode, Cutaneous 307 GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief 279 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 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