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
4759 Neurology devices
4001–4025 of 4759
Cleared Aug 23, 1993
CORDIS TUNNELER
K932273 · Cordis Corp.
GYK · Instrument, Shunt System Implantation · 102d
Cleared Aug 20, 1993
MEDTRONIC MODEL 3990 PNS LEAD
K925952 · Medtronic Vascular
GZF · Stimulator, Peripheral Nerve, Implanted (pain Relief) · 269d
Cleared Aug 20, 1993
GNOMOS STEREOTACTIC SYSTEM W/ NONINVASIVE FIXATION
K931991 · Nomos Corp.
HAW · Neurological Stereotaxic Instrument · 120d
Cleared Jul 29, 1993
PROBLOC INSULATED NEEDLES
K926349 · Life-Tech Intl., Inc.
GXZ · Electrode, Needle · 224d
Cleared Jul 21, 1993
MONOTRODE CUTANEOUS ELECTRODE
K915864 · Henley Intl.
GXY · Electrode, Cutaneous · 568d
Cleared Jul 21, 1993
VENTRI-CATH
K931989 · Gesco Intl., Inc.
JXG · Shunt, Central Nervous System And Components · 90d
Cleared Jul 08, 1993
DISPOSABLE PERFORATOR
K924242 · Codman & Shurtleff, Inc.
HBF · Drills, Burrs, Trephines & Accessories (compound, Powered) · 318d
Cleared Jul 02, 1993
NAVIGATOR & TRAVELER EVOKED POSTENTIAL PRODUCT
K930328 · Bio-Logic Systems Corp.
IKN · Electromyograph, Diagnostic · 161d
Cleared Jun 22, 1993
CADWELL 6200 A
K931428 · Cadwell Laboratories, Inc.
GWF · Stimulator, Electrical, Evoked Response · 88d
Cleared May 17, 1993
K-STIM CLEAR
K922202 · Katecho, Inc.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 371d
Cleared Apr 21, 1993
OJEMANN CORTICAL STIMULATOR
K924226 · Radionics, Inc.
GYC · Electrode, Cortical · 243d
Cleared Apr 15, 1993
ITC BUNJI PLATINUM EMBOLIZATION COIL
K925876 · Interventional Therapeutics Corp.
HCG · Device, Neurovascular Embolization · 147d
Cleared Apr 15, 1993
CAMINO VENTRICULAR TRANSDUCER ACCESSORY
K930221 · Camino Laboratories, Inc.
GWM · Device, Monitoring, Intracranial Pressure · 90d
Cleared Apr 15, 1993
CAMINO VENTRICULAR ACCESS DEVICE
K930222 · Camino Laboratories, Inc.
JXG · Shunt, Central Nervous System And Components · 90d
Cleared Apr 07, 1993
CLARUS ENDOSCOPIC BALL PROBE
K926048 · Clarus Medical Systems, Inc.
GZX · Instrument, Microsurgical · 127d
Cleared Apr 06, 1993
BITE BLOCK
K924304 · United States Endoscopy Group, Inc.
JXL · Block, Bite · 223d
Cleared Mar 30, 1993
PS MEDICAL CSF-ACCESS DEVICE
K913412 · Pudenz-Schulte Medical Research Corp.
JXG · Shunt, Central Nervous System And Components · 608d
Cleared Mar 29, 1993
INTERFERENTIAL STIMULATOR MODEL IMF4150/A
K925687 · Biomedical Life Systems, Inc.
LIH · Interferential Current Therapy · 137d
Cleared Mar 23, 1993
CADWELL SIERRA
K924723 · Cadwell Laboratories, Inc.
GWF · Stimulator, Electrical, Evoked Response · 183d
Cleared Mar 23, 1993
ITC BUNJI PLATINUM EMBOLIZATION COIL
K925523 · Interventional Therapeutics Corp.
HCG · Device, Neurovascular Embolization · 141d
Cleared Mar 18, 1993
MEDTRONIC MODEL 3487A PISCES-QUAD LEAD
K923931 · Medtronic Vascular
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 225d
Cleared Mar 18, 1993
MEDTRONIC MODEL 3080 PISCES-QUAD LEAD
K924522 · Medtronic Vascular
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 191d
Cleared Mar 18, 1993
THERA PULSE A ELECTRO NERVE STIMULATOR
K925686 · Biomedical Life Systems, Inc.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 126d
Cleared Mar 10, 1993
YHE GALILEO PLEIADE ELECTROENCEPHALOGRAPH
K923894 · Biosound, Inc.
GWQ · Full-montage Standard Electroencephalograph · 218d
Cleared Mar 10, 1993
DANTEC EVOLUTION
K924127 · Dantec Medical, Inc.
GWF · Stimulator, Electrical, Evoked Response · 205d

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All categories 4759 HAW Neurological Stereotaxic Instrument 342 GXY Electrode, Cutaneous 309 GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief 284 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 102 QJP Catheter, Percutaneous, Neurovasculature 97 GWG Endoscope, Neurological 87 NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes 74 GWM Device, Monitoring, Intracranial Pressure 72 OBP Transcranial Magnetic Stimulator 67