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

6334
Total
6279
Cleared
155d
Avg (2y)
1976
Since
6334 Neurology devices
2526–2550 of 6334
Cleared Aug 11, 2009
DISPOSABLE EMG NEEDLE ELECTRODES, MYOLINE, MYOLINE 2, MYOBOT,
K091410 · Spes Medica Srl
IKT · Electrode, Needle, Diagnostic Electromyograph · 90d
Cleared Aug 10, 2009
ZOOM-100DC
K082886 · Brainscope Company, Inc.
OLT · Non-normalizing Quantitative Electroencephalograph Software · 314d
Cleared Aug 06, 2009
MONTERIS MEDICAL UFO
K090240 · Monteris Medical,
HAW · Neurological Stereotaxic Instrument · 185d
Cleared Aug 05, 2009
RT300-SL, MODEL FA100052
K090750 · Restorative Therapies, Inc.
GZI · Stimulator, Neuromuscular, External Functional · 138d
Cleared Aug 03, 2009
LIFECARE ELECTRODES
K083302 · Everyway Medical Instruments Co.,Ltd
GXY · Electrode, Cutaneous · 266d
Cleared Jul 31, 2009
RAPID PROGRAMMER, VERSION 3.3.0
K091993 · Advanced Neuromodulation Systems, Inc. (Ans Inc.)
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 29d
Cleared Jul 30, 2009
MANTRA COMBO, MODEL MECS 320
K091236 · Mantra Intl. (Hk) , Ltd.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 94d
Cleared Jul 28, 2009
PMT HALO SYSTEM
K090733 · Pmt Corp.
HAX · Tong, Skull For Traction · 131d
Cleared Jul 22, 2009
PG471W , PG471/50W, PG474W, PG477W, PG479/32W, PG479/50W, PG479/75W FIAB DISPOSABLE ELECTRODES WITH CABLE FOR ELECTRO-ST
K091163 · Fiab Spa
GXY · Electrode, Cutaneous · 91d
Cleared Jul 17, 2009
STARLIGHT
K090587 · Orthomerica Products, Inc.
OAN · Orthosis, Cranial, Laser Scan · 135d
Cleared Jul 16, 2009
SMITH & NEPHEW RF CANNULATE
K090955 · Smith & Nephew, Inc.
GXI · Probe, Radiofrequency Lesion · 101d
Cleared Jul 07, 2009
SMARTSCREENER-PLUS2
K090579 · Intelligent Hearing Systems
GWJ · Stimulator, Auditory, Evoked Response · 126d
Cleared Jul 02, 2009
BIS CLICK SENSOR/CABLE
K091854 · Aspect Medical Systems, Inc.
GXY · Electrode, Cutaneous · 13d
Cleared Jul 01, 2009
S12X WITH ESAX OPTION
K082629 · Chatten Associates, Inc.
GYC · Electrode, Cortical · 295d
Cleared Jun 30, 2009
HYDROCOIL EMBOLIC SYSTEM (HYDROSOFT) AND MICROPLEX COIL SYSTEM (HYPERSOFT)
K091641 · MicroVention, Inc.
HCG · Device, Neurovascular Embolization · 26d
Cleared Jun 26, 2009
GUARDIAN 150 ELECTRODE
K083756 · Selectivemed Components, Inc.
GXY · Electrode, Cutaneous · 191d
Cleared Jun 25, 2009
LUMBOFIX CONDUCTIVE GARMENT, MODEL 420 BACK
K091317 · Bio-Medical Research, Ltd.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 52d
Cleared Jun 23, 2009
JIAJIAN SELF-ADHESIVE ELECTRODE
K090198 · Wuxi Jiajian Medical Instrument Co., Ltd.
GXY · Electrode, Cutaneous · 147d
Cleared Jun 23, 2009
RHYTHMLINK DISPOSABLE CONCENTRIC EMG NEEDLE, MODEL D039032252R
K091055 · Rhythmlink International, LLC
IKT · Electrode, Needle, Diagnostic Electromyograph · 71d
Cleared Jun 23, 2009
RHYTHMLINK DISPOSABLE MONOPOLAR EMG NEEDLE, MODEL TFDN26032252R
K091056 · Rhythmlink International, LLC
IKT · Electrode, Needle, Diagnostic Electromyograph · 71d
Cleared Jun 22, 2009
MICROPLEX COIL SYSTEM-COSMOS
K090891 · MicroVention, Inc.
HCG · Device, Neurovascular Embolization · 84d
Cleared Jun 08, 2009
NUVASIVE NEURO VISION SYSTEM
K090298 · Nuvasive, Inc.
GWF · Stimulator, Electrical, Evoked Response · 122d
Cleared Jun 05, 2009
EMPI ACTIVE TRANSCUTANEOUS NERVE STIMULATOR
K090922 · Empi
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 65d
Cleared Jun 05, 2009
RS- LB LOW BACK CONDUCTIVE GARMENT, MODEL RS-LBM, RS-LBL, RS-FBG FULL BACK CONDUCTIVE GARMENT , MODEL RS-FBG
K090951 · Rs Medical
GXY · Electrode, Cutaneous · 63d
Cleared Jun 02, 2009
PENTA LEAD KITS, MODELS: 3227-3234
K090907 · Advanced Neuromodulation Systems
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 62d

Looking for a specific neurology device? Search by device name, K-number or manufacturer.

Search all Neurology 510(k) devices

Filter by Product Code

All categories 6334 GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief 605 GXY Electrode, Cutaneous 438 HAW Neurological Stereotaxic Instrument 417 JXG Shunt, Central Nervous System And Components 260 NUH Stimulator, Nerve, Transcutaneous, Over-the-counter 218 GWQ Full-montage Standard Electroencephalograph 189 HCG Device, Neurovascular Embolization 187 HCC Device, Biofeedback 172 GWF Stimulator, Electrical, Evoked Response 140 GZB Stimulator, Spinal-cord, Implanted (pain Relief) 133 NRY Catheter, Thrombus Retriever 117 GWM Device, Monitoring, Intracranial Pressure 105 QJP Catheter, Percutaneous, Neurovasculature 102 GWG Endoscope, Neurological 94 NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes 81