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
2226–2250 of 6334
Cleared Sep 25, 2012
CUSTOM CRANIOFACIAL IMPLANT (CCI)
K121755 · Kelyniam Global, Inc.
GXN · Plate, Cranioplasty, Preformed, Non-alterable · 102d
Cleared Sep 21, 2012
NIMBUS ELECTROSURGICAL RADIOFREQUENCY MULTITINED EXPANDABLE ELECTRODE
K121773 · Biomerics
GXI · Probe, Radiofrequency Lesion · 95d
Cleared Sep 19, 2012
MEB-2300A NEUROPACK EVOKED POTENTIAL AND EMG MEASURING SYSTEM
K120397 · Nihon Kohden Corp.
GWF · Stimulator, Electrical, Evoked Response · 224d
Cleared Sep 19, 2012
SLEEP PROFILER
K120450 · Advanced Brain Monitoring, Inc.
OLZ · Automatic Event Detection Software For Polysomnograph With Electroencephalograph · 218d
Cleared Sep 14, 2012
PEEK CUSTOMIZED CRAIAL IMPLANT KIT
K121153 · Stryker
GWO · Plate, Cranioplasty, Preformed, Alterable · 151d
Cleared Sep 10, 2012
INTEGRA CAMINO ICP MONITOR
K121573 · Intrgra Lifesciences Corporation
GWM · Device, Monitoring, Intracranial Pressure · 104d
Cleared Sep 10, 2012
DELICOT
K121822 · American Surgical Company, LLC
HBA · Neurosurgical Paddie · 81d
Cleared Sep 07, 2012
MINI PATCH
K121353 · Well-Life Healthcare Limited
NUH · Stimulator, Nerve, Transcutaneous, Over-the-counter · 126d
Cleared Sep 04, 2012
TENS BACK PAIN RELIEF SYSTEM
K113321 · Savia Limited
NUH · Stimulator, Nerve, Transcutaneous, Over-the-counter · 299d
Cleared Aug 30, 2012
CRAINFIX 2 TITANIUM CLAMP SYSTEM
K122353 · Aesculap, Inc.
GXN · Plate, Cranioplasty, Preformed, Non-alterable · 27d
Cleared Aug 27, 2012
TRITON ELECTRIC HIGH TORQUE HANDPIECE AND SOFTWARE MODULE
K121264 · Medtronic Surgical Technologies
HBE · Drills, Burrs, Trephines & Accessories (simple, Powered) · 123d
Cleared Aug 22, 2012
OSTEOMED CRANIAL DISTRACTION SYSTEM
K121304 · Osteomed
PBJ · Cranial Distraction System · 113d
Cleared Aug 20, 2012
THE PAIN PILOT (A.K.A PAIN PILOT)
K120500 · Hollywog, LLC
NUH · Stimulator, Nerve, Transcutaneous, Over-the-counter · 181d
Cleared Aug 20, 2012
DYNATRON THERMOSTIM PROBE-DONE
K120835 · Dynatronics Corporation
GXY · Electrode, Cutaneous · 153d
Cleared Aug 16, 2012
WITOUCH PRO
K120398 · Hollywog, LLC
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 190d
Cleared Aug 08, 2012
OSTEOSYMBIONICS PEEK CRANIAL IMPLANT
K121102 · Osteosymbionics, LLC
GXN · Plate, Cranioplasty, Preformed, Non-alterable · 119d
Cleared Aug 03, 2012
TREVO RETRIEVER
K120961 · Concentric Medical, Inc.
NRY · Catheter, Thrombus Retriever · 126d
Cleared Aug 03, 2012
BE PLUS LTM AMPLIFIER GWI AMPLIFIER
K121996 · Eb Neuro S.P.A.
GWL · Amplifier, Physiological Signal · 25d
Cleared Aug 03, 2012
HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEM
K122118 · Codman & Shurtleff, Inc.
JXG · Shunt, Central Nervous System And Components · 17d
Cleared Aug 02, 2012
SENSUS
K121184 · Neurometrix, Inc.
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 106d
Cleared Jul 31, 2012
ATOM 1 (MODEL: BRC 2200)
K121578 · Bioelectric Research Corporation
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 62d
Cleared Jul 30, 2012
AGELESS WONDER FACIAL MUSCLE STIMULATION SYSTEM
K120511 · Leto Enterprise , Ltd.
NFO · Stimulator, Transcutaneous Electrical, Aesthetic Purposes · 160d
Cleared Jul 27, 2012
IO-TOME DEVICE
K113073 · Baxano, Inc.
HAE · Rongeur, Manual · 284d
Cleared Jul 27, 2012
ELECTRONIC PULSE MASSAGER TENS ELECTRONIC PULSE MASSAGER
K113544 · Prospera Corporation
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 239d
Cleared Jul 26, 2012
MICROTARGETING XL STAR DRIVE SYSTEM
K121950 · FHC, Inc.
HAW · Neurological Stereotaxic Instrument · 23d

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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