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
4750 Neurology devices
3476–3500 of 4750
Cleared Feb 01, 1999
VECTRA PRO MODELS 2 AND 4
K982324 · Chattanooga Group, Inc.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 214d
Cleared Jan 28, 1999
PHILIPS EASYGUIDE
K981480 · Philips Medical Systems, Inc.
HAW · Neurological Stereotaxic Instrument · 279d
Cleared Jan 27, 1999
ENDIUS SPINE ENDOSCOPE
K982819 · Endius, Inc.
GWG · Endoscope, Neurological · 169d
Cleared Jan 26, 1999
MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM, MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM POLE CLAMP, MEDTRONIC PS MEDICL
K983799 · Medtronic PS Medical
GWM · Device, Monitoring, Intracranial Pressure · 90d
Cleared Jan 14, 1999
STEALTHSTATION SYSTEM
K983670 · Surgical Navigation Technologies, Inc.
HAW · Neurological Stereotaxic Instrument · 87d
Cleared Jan 13, 1999
SNN SCOUT
K982570 · I.S.G. Technologies, Inc.
HAW · Neurological Stereotaxic Instrument · 174d
Cleared Jan 11, 1999
NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODES
K983597 · Medicotest, Inc.
GXZ · Electrode, Needle · 90d
Cleared Jan 07, 1999
XYZ SYSTEM
K983550 · Bio-Monitoring International Corp.
HCC · Device, Biofeedback · 90d
Cleared Dec 30, 1998
NEUROMAG VECTORVIEW
K984401 · Philips Medical Systems (Cleveland), Inc.
OLX · Source Localization Software For Electroencephalograph Or Magnetoencephalograph · 21d
Cleared Dec 18, 1998
SUNDT SLIM-LINE ANEURYSM CLIP APPLIER
K982379 · Johnson & Johnson Professionals, Inc.
HCI · Applier, Aneurysm Clip · 163d
Cleared Dec 18, 1998
AESCULAP MINOP SYSTEM
K983365 · Aesculap, Inc.
GWG · Endoscope, Neurological · 85d
Cleared Dec 18, 1998
EVERLAST NEUROSTIMULATION ELECTRODES 2X 2,MODEL # EL2020
K983741 · Axelgaard Mfg. Co., Ltd.
GXY · Electrode, Cutaneous · 57d
Cleared Dec 18, 1998
YASARGIL TITANIUM ANEURYSM CLIPS
K983758 · Aesculap, Inc.
HCH · Clip, Aneurysm · 53d
Cleared Dec 18, 1998
NON-INVASIVE DYNAMIC REFERENCE FRAME (DRF) FOR OPTICAL TRACKING SYSTEM, MODEL OTS
K984245 · Radionics, Inc.
HAW · Neurological Stereotaxic Instrument · 21d
Cleared Dec 16, 1998
MEDTRONIC PS MEDICAL INNERVISION VENTRICULAR CATHETER, 15CM MODEL 99102
K983331 · Medtronic PS Medical
HCA · Catheter, Ventricular · 85d
Cleared Dec 09, 1998
BATCH #6060 CONDUCTIVE GEL
K983964 · Skylark Device Co., Ltd.
GYB · Media, Electroconductive · 33d
Cleared Dec 08, 1998
CRX DIAMOND VALVE
K974096 · Phoenix Biomedical Corp.
JXG · Shunt, Central Nervous System And Components · 404d
Cleared Dec 04, 1998
STEALTHSTATION TREATMENT GUIDANCE PLAFFORM
K983397 · Surgical Navigation Technologies, Inc.
HAW · Neurological Stereotaxic Instrument · 70d
Cleared Dec 01, 1998
AMBULATORY EEG/SLEEP RECORDER AND ACCESSORIES, MODEL # SSR3201
K983072 · Nihon Kohden America, Inc.
OLV · Standard Polysomnograph With Electroencephalograph · 90d
Cleared Nov 25, 1998
ACUTRON MENTOR MODEL 961
K981976 · Microcurrent Research, Inc.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 177d
Cleared Nov 25, 1998
BSM- BONE SUBSTITUTE MATERIAL
K983009 · Etex Corp.
GXP · Methyl Methacrylate For Cranioplasty · 89d
Cleared Nov 25, 1998
MODIFICATION TO BIO-LOGIC SLEEPSCAN
K983913 · Bio-Logic Systems Corp.
OLV · Standard Polysomnograph With Electroencephalograph · 21d
Cleared Nov 23, 1998
STEALTHSTATION TREATMENT GUIDANCE PLATFORM
K981768 · Surgical Navigation Technologies, Inc.
HAW · Neurological Stereotaxic Instrument · 188d
Cleared Nov 20, 1998
NEUROMAP
K981820 · Radionics, Inc.
GZL · Electrode, Depth · 182d
Cleared Nov 18, 1998
OPTICAL TRACKING SYSTEM WITH SURFACE MATCHING MODULE, MODEL OTS
K983669 · Radionics, Inc.
HAW · Neurological Stereotaxic Instrument · 30d

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All categories 4750 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