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
4721 Neurology devices
2176–2200 of 4721
Cleared Oct 31, 2012
MODIFIED TREVO RETRIEVER
K122478 · Concentric Medical, Inc.
NRY · Catheter, Thrombus Retriever · 78d
Cleared Oct 17, 2012
QBTES
K122149 · Qbtech AB
LQD · Recorder, Attention Task Performance · 90d
Cleared Oct 15, 2012
REUSABLE CUTANEOUS ELECTRODE
K121483 · Ampcare, LLC
GXY · Electrode, Cutaneous · 150d
Cleared Oct 12, 2012
BIOMET MICROFIXATION NEURO PLATING SYSTEM
K121624 · Biomet Microfixation
GWO · Plate, Cranioplasty, Preformed, Alterable · 133d
Cleared Sep 27, 2012
TYPE 1077 ACCUSCREEN
K122067 · Gn Otometrics
GWJ · Stimulator, Auditory, Evoked Response · 73d
Cleared Sep 27, 2012
KARL STORZ NAVIGATIONPANEL UNIT (NPU) SYSTEM
K122096 · KARL STORZ Endoscopy-America, Inc.
HAW · Neurological Stereotaxic Instrument · 73d
Cleared Sep 25, 2012
STERLING MEDICAL IMPULSE 3 STIMULATOR
K121305 · Armstrong Industries, Inc. Dha Mediquip Int. Dha S
GZJ · Stimulator, Nerve, Transcutaneous, For Pain Relief · 147d
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

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All categories 4721 HAW Neurological Stereotaxic Instrument 341 GXY Electrode, Cutaneous 306 GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief 276 JXG Shunt, Central Nervous System And Components 222 NUH Stimulator, Nerve, Transcutaneous, Over-the-counter 211 HCG Device, Neurovascular Embolization 173 GWQ Full-montage Standard Electroencephalograph 140 NRY Catheter, Thrombus Retriever 114 GZB Stimulator, Spinal-cord, Implanted (pain Relief) 113 GWF Stimulator, Electrical, Evoked Response 100 QJP Catheter, Percutaneous, Neurovasculature 97 GWG Endoscope, Neurological 87 NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes 74 GWM Device, Monitoring, Intracranial Pressure 71 OBP Transcranial Magnetic Stimulator 67