FDA Review Panel · NE

FDA 510(k) Neurology Devices

About Neurology Devices

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

6214
Total
6160
Cleared
148d
Avg days
1976
Since
554 Neurology devices
401–425 of 554
Cleared Mar 27, 2024
MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter
K233201 · Penumbra, Inc.
QJP · Catheter, Percutaneous, Neurovasculature · 181d
Cleared Mar 25, 2024
Modus IR
K231986 · Synaptive Medical, Inc.
IZI · System, X-ray, Angiographic · 264d
Cleared Mar 25, 2024
MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)
K234080 · Soterix Medical, Inc.
GWF · Stimulator, Electrical, Evoked Response · 94d
Cleared Mar 25, 2024
Transcutaneous Electrical Nerve Stimulator (9029SCM)
K240292 · Hong Kong Etech Groups Limited
NUH · Stimulator, Nerve, Transcutaneous, Over-the-counter · 53d
Cleared Mar 22, 2024
NeuroStar Advanced Therapy System (All previously cleared models)
K231926 · Neuronetics, Inc.
OBP · Transcranial Magnetic Stimulator · 266d
Cleared Mar 21, 2024
Electrical Stimulator System
K232439 · Gymmax Technology Shenzen Co., Ltd.
NUH · Stimulator, Nerve, Transcutaneous, Over-the-counter · 220d
Cleared Mar 19, 2024
Amydi-med Disposable Non-invasive EEG electrodes
K240668 · Shenzhen Amydi-Med Electrics Tech Co., Ltd.
GXY · Electrode, Cutaneous · 11d
Cleared Mar 15, 2024
APRO 55 Catheter
K234115 · Alembic, LLC
DQY · Catheter, Percutaneous · 79d
Cleared Mar 15, 2024
STARband 3D
K240466 · Orthomerica Products, Inc.
OAN · Orthosis, Cranial, Laser Scan · 28d
Cleared Mar 14, 2024
Myriad SPECTRA Light Source
K232567 · Nico Corporation
QFX · Diagnostic Neurosurgical Microscope Filter · 203d
Cleared Mar 08, 2024
Esperance Distal Access Catheter
K231056 · Wallaby Medical
QJP · Catheter, Percutaneous, Neurovasculature · 330d
Cleared Mar 08, 2024
SleepStageML
K233438 · Beacon Biosignals, Inc.
OLZ · Automatic Event Detection Software For Polysomnograph With Electroencephalograph · 147d
Cleared Mar 06, 2024
evoDrill Cranial Perforator
K231403 · Evonos GmbH & Co. KG
HBF · Drills, Burrs, Trephines & Accessories (compound, Powered) · 296d
Cleared Mar 01, 2024
Muscle Stimulator
K231648 · Shenzhen Yiran Intelligent Co., Ltd.
NUH · Stimulator, Nerve, Transcutaneous, Over-the-counter · 270d
Cleared Mar 01, 2024
S21 OTC Transcutaneous Electrical Nerve Stimulator
K233095 · Micro Current Technology, Inc.
NUH · Stimulator, Nerve, Transcutaneous, Over-the-counter · 157d
Cleared Feb 29, 2024
APRO 55 Catheter and Alembic Aspiration Tubing
K232971 · Alembic, LLC
NRY · Catheter, Thrombus Retriever · 161d
Cleared Feb 26, 2024
TENS device-HeadaTerm 2 (Model: YF-HT2)
K230782 · Wat Medical Technology, Inc.
PCC · Stimulator, Nerve, Electrical, Transcutaneous, For Migraine · 341d
Cleared Feb 23, 2024
ENSO (Model 2)
K233784 · Hinge Health, Inc.
NUH · Stimulator, Nerve, Transcutaneous, Over-the-counter · 88d
Cleared Feb 16, 2024
Montage Flowable Settable, Resorbable Bone Paste
K232771 · Orthocon, Inc.
GXP · Methyl Methacrylate For Cranioplasty · 158d
Cleared Feb 16, 2024
Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System
K240137 · Neos Surgery S.L
GXR · Cover, Burr Hole · 29d
Cleared Feb 15, 2024
EpiMonitor
K232915 · Empatica S.R.L.
POS · Physiological Signal Based Seizure Monitoring System · 149d
Cleared Feb 12, 2024
Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W)
K233092 · Chongqing Rob Linka Science and Technology Co., Ltd.
NUH · Stimulator, Nerve, Transcutaneous, Over-the-counter · 139d
Cleared Feb 12, 2024
NerveTape
K233533 · Biocircuit Technologies, Inc.
JXI · Cuff, Nerve · 102d
Cleared Feb 12, 2024
Facial Toning device (UIC-189)
K233667 · Body Trim Industrial Co., Ltd.
NFO · Stimulator, Transcutaneous Electrical, Aesthetic Purposes · 89d
Cleared Feb 09, 2024
ZapStim Controller Application (Z1023)
K233631 · Revital Lab, Inc.
OBP · Transcranial Magnetic Stimulator · 88d

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All categories 554 QJP Catheter, Percutaneous, Neurovasculature 52 NUH Stimulator, Nerve, Transcutaneous, Over-the-counter 40 HAW Neurological Stereotaxic Instrument 34 NRY Catheter, Thrombus Retriever 32 GXY Electrode, Cutaneous 22 OBP Transcranial Magnetic Stimulator 22 NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes 22 HCG Device, Neurovascular Embolization 14 MOF Guide, Wire, Catheter, Neurovasculature 13 JXG Shunt, Central Nervous System And Components 12 HBE Drills, Burrs, Trephines & Accessories (simple, Powered) 12 OMB Automatic Event Detection Software For Full-montage Electroencephalograph 11 JXI Cuff, Nerve 9 GWF Stimulator, Electrical, Evoked Response 8 DQY Catheter, Percutaneous 7