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
3976–4000 of 4759
Cleared Mar 22, 1994
CERVICAL SELF-RETAINING RETRACTOR
K935529 · T. Korossurgical Instruments Corp.
GZT · Retractor, Self-retaining, For Neurosurgery · 126d
Cleared Mar 22, 1994
NOMOS STEREOTACTIC BIOPSY INSTRUMENTS
K936019 · Nomos Corp.
HAW · Neurological Stereotaxic Instrument · 95d
Cleared Mar 14, 1994
HOME MICROCURRENT HMC
K935132 · Medical Devices, Inc.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 137d
Cleared Mar 07, 1994
MICROSENSOR INTRACRANIAL PRESSURE TRANSDUCER
K914479 · Codman & Shurtleff, Inc.
GWM · Device, Monitoring, Intracranial Pressure · 881d
Cleared Mar 03, 1994
CEEGRAPH, MODIFICATION
K933233 · Bio-Logic Systems Corp.
GWQ · Full-montage Standard Electroencephalograph · 316d
Cleared Mar 02, 1994
CORDIS POLYPROPYLENE BURR HOLE RESERVOIR
K925810 · Cordis Corp.
JXG · Shunt, Central Nervous System And Components · 470d
Cleared Mar 02, 1994
SPACELABS MEDICAL MODEL 90481 EEG MODULE
K932842 · Spacelabs Medical, Inc.
GWQ · Full-montage Standard Electroencephalograph · 264d
Cleared Feb 23, 1994
FLEXMATE
K934619 · Medical Devices, Inc.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 149d
Cleared Feb 03, 1994
MEDTRONIC MODEL 3625 SCREENER SYSTEM
K932948 · Medtronic Vascular
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 231d
Cleared Feb 03, 1994
TOPOGRAPHIC BRAIN MAPPING OPTION
K934050 · Biosound, Inc.
OLT · Non-normalizing Quantitative Electroencephalograph Software · 168d
Cleared Jan 07, 1994
MAYFIELD RADIOLUCENT SKULL CLAMP
K934289 · Ohio Medical Instrument Co., Inc.
HBL · Holder, Head, Neurosurgical (skull Clamp) · 127d
Cleared Dec 10, 1993
DISPOSABLE PERFORATOR
K933894 · Codman & Shurtleff, Inc.
HBF · Drills, Burrs, Trephines & Accessories (compound, Powered) · 122d
Cleared Dec 08, 1993
PHOTOSTRESS RECOVERY TESTER
K933814 · Storz Instrument Co.
GXY · Electrode, Cutaneous · 126d
Cleared Nov 22, 1993
CODMAN LASER NEUROENDOSCOPE
K924977 · Codman & Shurtleff, Inc.
GWG · Endoscope, Neurological · 417d
Cleared Nov 19, 1993
CORTICAL SURF EPILEPSY ELECT DEPTH ELEC EPILEP MON
K926424 · Radionics, Inc.
GYC · Electrode, Cortical · 331d
Cleared Nov 19, 1993
V/P AND L/P CATHETER PASSERS
K934391 · Radionics, Inc.
GYK · Instrument, Shunt System Implantation · 71d
Cleared Nov 09, 1993
ITC CONTOUR EMBOLI, MODIFICATION
K914866 · Interventional Therapeutics Corp.
HCG · Device, Neurovascular Embolization · 742d
Cleared Nov 09, 1993
DANTEC MAGLITE MAGNETIC STIMULATOR (MAGLITE)
K931923 · Dantec Medical, Inc.
GWF · Stimulator, Electrical, Evoked Response · 207d
Cleared Oct 19, 1993
E*NET NEUROMONITORING SYSTEM
K930080 · Physiometrix, Inc.
GWQ · Full-montage Standard Electroencephalograph · 285d
Cleared Sep 28, 1993
MAYFIELD* A-2000 SKULL CLAMP
K932807 · Ohio Medical Instrument Co., Inc.
HBL · Holder, Head, Neurosurgical (skull Clamp) · 111d
Cleared Sep 28, 1993
MAYFIELD ADULT DISPOSABLE SKULL PIN
K932860 · Ohio Medical Instrument Co., Inc.
HBL · Holder, Head, Neurosurgical (skull Clamp) · 109d
Cleared Sep 14, 1993
DISPOSABLE PEEL-AWAY INTRODUCER SHEATH
K931973 · Neuro Navigational Corp.
GWG · Endoscope, Neurological · 145d
Cleared Sep 10, 1993
PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER
K930606 · Pudenz-Schulte Medical Research Corp.
GYK · Instrument, Shunt System Implantation · 217d
Cleared Sep 10, 1993
DISPOSABLE GRASPING FORCEP
K933244 · Neuro Navigational Corp.
GWG · Endoscope, Neurological · 70d
Cleared Aug 31, 1993
DANTEC MAGNETIC STIMULATOR MAGPRO
K926516 · Dantec Medical, Inc.
GWF · Stimulator, Electrical, Evoked Response · 244d

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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