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
4748 Neurology devices
3251–3275 of 4748
Cleared Feb 23, 2001
ORTHOPILOT
K003347 · Kinamed, Inc.
HAW · Neurological Stereotaxic Instrument · 121d
Cleared Feb 22, 2001
Z-TOUCH
K003268 · Brainlab AG
HAW · Neurological Stereotaxic Instrument · 127d
Cleared Feb 20, 2001
MICROSPEED EC MOTORSYSTEM GD650/GD653
K003612 · Aesculap, Inc.
HBC · Motor, Drill, Electric · 90d
Cleared Feb 09, 2001
REMVIEW SLEEP RECORDER, MODEL 320
K003499 · Respironics, Inc.
LEL · Device, Sleep Assessment · 88d
Cleared Feb 09, 2001
64 CHANNEL EEG / MODEL NUMBER EX-NW-64
K010150 · Excel Tech. , Ltd.
GWQ · Full-montage Standard Electroencephalograph · 23d
Cleared Feb 05, 2001
MULTI INTERFERENTIAL STIMULATOR, MODEL TR-841
K993600 · Nisha Communication Industries
LIH · Interferential Current Therapy · 469d
Cleared Feb 02, 2001
ANALGESIC PULSER, MODEL AP-439
K993229 · Johari Electro-Tech Co.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 494d
Cleared Feb 01, 2001
EEG WITH VIDEO, MODEL EX-NW
K010091 · Excel Tech. , Ltd.
GWQ · Full-montage Standard Electroencephalograph · 21d
Cleared Jan 29, 2001
YASARGIL PERMANENT ANEURYSM CLIPS
K003519 · Aesculap, Inc.
HCH · Clip, Aneurysm · 75d
Cleared Jan 24, 2001
STIMATE N601 TENS
K003487 · Everyway Medical Instruments Co.,Ltd
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 72d
Cleared Jan 24, 2001
STRYKER REMOTE SURGICAL PLANNING SYSTEM
K004027 · Stryker Instruments
HAW · Neurological Stereotaxic Instrument · 28d
Cleared Jan 19, 2001
RENEW NEUROSTIMULATION SYSTEM
K000852 · Advanced Neuromodulation Systems
GZF · Stimulator, Peripheral Nerve, Implanted (pain Relief) · 310d
Cleared Jan 17, 2001
NC-STAT
K003508 · Neurometrix, Inc.
JXE · Device, Nerve Conduction Velocity Measurement · 64d
Cleared Jan 04, 2001
STRYKER NAVIGATION SYSTEM-SPINE & FLUOROSCOPY MODULES
K003111 · Stryker Instruments
HAW · Neurological Stereotaxic Instrument · 92d
Cleared Dec 21, 2000
BIO-LOGIC SLEEPSCAN NETLINK
K003681 · Bio-Logic Systems Corp.
OLV · Standard Polysomnograph With Electroencephalograph · 21d
Cleared Dec 20, 2000
HAKIM PROGRAMMER AND TRANSMITTER
K003564 · Codman & Shurtleff, Inc.
JXG · Shunt, Central Nervous System And Components · 30d
Cleared Nov 24, 2000
DETACH 18 AND DETACH 11, NEUROLOGICAL EMBOLIZATION COIL SYSTEM
K000651 · Cook, Inc.
HCG · Device, Neurovascular Embolization · 270d
Cleared Nov 07, 2000
KM-10 TENS ELECTRODE
K000870 · Katecho, Inc.
GXY · Electrode, Cutaneous · 232d
Cleared Nov 03, 2000
KSEA MINIATURE NEUROENDOSCOPE
K002704 · KARL STORZ Endoscopy-America, Inc.
GWG · Endoscope, Neurological · 65d
Cleared Oct 25, 2000
BURR HOLE COVER, MODEL XX
K001096 · Image-Guided Neurologics, Inc.
GXR · Cover, Burr Hole · 204d
Cleared Oct 24, 2000
ANSPACH ANGLED MICRONOSE ATTACHMENT
K002903 · The Anspach Effort, Inc.
HBE · Drills, Burrs, Trephines & Accessories (simple, Powered) · 36d
Cleared Oct 23, 2000
BAYLIS PAIN MANAGEMENT PROBE/PMP-20-145 AND BAYLIS PAIN MANAGEMENT CONNECTOR CABLE/PMX-BAY-BAY
K002389 · Baylis Medical Co., Inc.
GXI · Probe, Radiofrequency Lesion · 80d
Cleared Oct 23, 2000
NEUROMAP WITH NEURO 100
K002773 · Radionics, Inc.
GWF · Stimulator, Electrical, Evoked Response · 47d
Cleared Oct 23, 2000
KSEA NEURO-FIBERSCOPE
K002788 · KARL STORZ Endoscopy-America, Inc.
GWG · Endoscope, Neurological · 46d
Cleared Oct 20, 2000
DA VINCHI EEG AND EMG/EP SYSTEMS
K000963 · Airsep Corp.
GWF · Stimulator, Electrical, Evoked Response · 210d

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All categories 4748 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 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