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
2426–2450 of 6334
Cleared Nov 15, 2010
SCALP DURA RETRACTOR, MODEL KS00474
K093054 · KARL STORZ Endoscopy-America, Inc.
GZT · Retractor, Self-retaining, For Neurosurgery · 411d
Cleared Nov 09, 2010
AESCULAP- MEITHKE PROGAV PROGRAMMABLE SHUNT SYSTEM
K103003 · Aesculap, Inc.
JXG · Shunt, Central Nervous System And Components · 28d
Cleared Oct 29, 2010
NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701
K092477 · Neurowave Systems, Inc.
OMC · Reduced- Montage Standard Electroencephalograph · 443d
Cleared Oct 26, 2010
ELEKTA NEUROMAG WITH MAXFILTER
K091393 · Elekta Neuromag OY
OLX · Source Localization Software For Electroencephalograph Or Magnetoencephalograph · 533d
Cleared Oct 26, 2010
MULTI-LEAD TRIALING CABLE MODEL 355531
K102523 · Medtronic, Inc.
GZB · Stimulator, Spinal-cord, Implanted (pain Relief) · 54d
Cleared Oct 25, 2010
CRANIAL LOOP CRANIAL BONE FIXATION SYSTEM
K101235 · Neos Surgery S.L
GXR · Cover, Burr Hole · 175d
Cleared Oct 15, 2010
TARGET DETACHABLE COIL
K102672 · Boston Scientific Corp
HCG · Device, Neurovascular Embolization · 29d
Cleared Oct 12, 2010
COOL LINE CATHETER, MODEL CL-2295A, ICY CATHETER, MODEL IC-3893A AND QUATTRO CATHETER, MODEL IC-4593
K101987 · Zoll Circulation
NCX · System, Hypothermia, Intravenous, Cooling · 90d
Cleared Oct 07, 2010
DISPOSABLE AND REUSABLE CONCENTRIC NEEDLES / DISPOSABLE AND REUSABLE MONOPOLAR NEEDLE
K092973 · Bionen S.A.S.
IKT · Electrode, Needle, Diagnostic Electromyograph · 377d
Cleared Sep 23, 2010
ROSA SURGICAL DEVICE
K101791 · Medtech S.A.S
HAW · Neurological Stereotaxic Instrument · 87d
Cleared Sep 23, 2010
NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY
K102018 · Synthes USA Products, LLC
GXP · Methyl Methacrylate For Cranioplasty · 66d
Cleared Sep 17, 2010
CRYO-TOUCH II
K102021 · Myoscience, Inc.
GXH · Device, Surgical, Cryogenic · 60d
Cleared Sep 03, 2010
SUPERIOR STARBURST REUSABLE SELF-ADHERING TENS/NMES/FES STIMULATING ELECTRODE
K100418 · Covidien
GXY · Electrode, Cutaneous · 199d
Cleared Aug 31, 2010
TENS STIMULATOR, MODELS 2800 AND 3000
K102014 · Koalaty Products, Inc.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 46d
Cleared Aug 24, 2010
LEGEND POWER ADAPTER MODEL: 6475000
K101168 · Medtronic Sofamor Danek
HBB · Motor, Drill, Pneumatic · 120d
Cleared Aug 19, 2010
DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULATOR PROBE, BIPOLAR SIDE BY SIDE
K100912 · Kirwan Surgical Products, Inc.
GXZ · Electrode, Needle · 140d
Cleared Aug 12, 2010
AESCULAP PEEK CRANIOFIX
K091692 · Aesculap, Inc.
GXR · Cover, Burr Hole · 428d
Cleared Aug 11, 2010
PROTEKTOR 32
K093304 · Natus Medical, Inc.
GWF · Stimulator, Electrical, Evoked Response · 294d
Cleared Aug 10, 2010
DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20
K101372 · Baylis Medical Co., Inc.
GXI · Probe, Radiofrequency Lesion · 85d
Cleared Aug 10, 2010
LIFELINES PHOTIC STIMULATOR
K101691 · Lifelines , Ltd.
GWE · Stimulator, Photic, Evoked Response · 55d
Cleared Aug 05, 2010
MULTI-PURPOSE HEALTH DEVICE
K093322 · Upc Medical Supplies, Inc. Dba United Pacific Co.
BWK · Stimulator, Electro-acupuncture · 286d
Cleared Aug 05, 2010
SALUTUNNEL NERVE PROTECTOR, MODEL ED-20329, ED-20330, ED-20331
K100382 · Salumedica, LLC
JXI · Cuff, Nerve · 170d
Cleared Jul 30, 2010
VIGILANT EEG MONITOR MODEL VIGILANT 2.0
K101386 · Infinite Biomedical Technologies, LLC
GWQ · Full-montage Standard Electroencephalograph · 73d
Cleared Jul 23, 2010
MODIFICATION TO: MICROBLADE SHAVER AND ACCESSORIES
K100958 · Baxano, Inc.
HAE · Rongeur, Manual · 107d
Cleared Jul 15, 2010
XINIWAVE, MODEL XW-18
K100441 · International Trade Group, Inc.
NUH · Stimulator, Nerve, Transcutaneous, Over-the-counter · 148d

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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