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
426–450 of 554
Cleared Feb 08, 2024
Vecttor VT-300
K231575 · Artaflex, Inc.
LIH · Interferential Current Therapy · 253d
Cleared Feb 04, 2024
X-trodes System M
K232210 · X-Trodes
GWL · Amplifier, Physiological Signal · 193d
Cleared Feb 04, 2024
CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)
K232890 · Integra Lifesciences Production Corporation
GWM · Device, Monitoring, Intracranial Pressure · 139d
Cleared Feb 01, 2024
BTL-99-OC
K230657 · BTL Industries, Inc.
QCI · Transcranial Magnetic Stimulation System For Obsessive-compulsive Disorder · 329d
Cleared Jan 29, 2024
Rebuilder Nerve Guidance Conduit
K230794 · Celestray Biotech Company, LLC.,
JXI · Cuff, Nerve · 313d
Cleared Jan 22, 2024
Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G, F100, MINI-TENS-COMB, RC101I, TENS3500)
K231423 · Shenzhen Roundwhale Technology Co. , Ltd.
NUH · Stimulator, Nerve, Transcutaneous, Over-the-counter · 250d
Cleared Jan 19, 2024
Distal Access Catheter
K231218 · Accumedical Beijing , Ltd.
QJP · Catheter, Percutaneous, Neurovasculature · 266d
Cleared Jan 19, 2024
Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A)
K233461 · Hi-Dow International, Inc.
NUH · Stimulator, Nerve, Transcutaneous, Over-the-counter · 88d
Cleared Jan 17, 2024
Bactiseal Catheters
K233445 · Integra Lifesciences Production Corporation
JXG · Shunt, Central Nervous System And Components · 90d
Cleared Jan 17, 2024
Cerenovus Large Bore Catheter
K233988 · Cerenovus, Inc.
NRY · Catheter, Thrombus Retriever · 30d
Cleared Jan 16, 2024
Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System®
K233293 · Neurosigma, Inc.
QGL · Transcutaneous Nerve Stimulator For Adhd · 109d
Cleared Jan 12, 2024
SmartFrame OR
K233141 · ClearPoint Neuro, Inc.
HAW · Neurological Stereotaxic Instrument · 107d
Cleared Jan 12, 2024
ClearPoint Bone Screw Fiducials
K233144 · ClearPoint Neuro, Inc.
HAW · Neurological Stereotaxic Instrument · 107d
Cleared Jan 12, 2024
ClearPointer Optical Navigation Wand
K233155 · ClearPoint Neuro, Inc.
HAW · Neurological Stereotaxic Instrument · 107d
Cleared Jan 11, 2024
Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning, AC1001, AC1002, AC1003, AC1003, AC1004, AC1005
K232995 · Shenzhen Roundwhale Technology Co. , Ltd.
GXY · Electrode, Cutaneous · 111d
Not Cleared Jan 11, 2024
BrainSee
DEN220066 · Darmiyan, Inc.
QWT · Prognostic Assessment Software Of Mild Cognitive Impairment · 469d
Cleared Jan 10, 2024
Numen Coil Embolization System
K232955 · MicroPort NeuroTech (Shanghai) Co., Ltd.
HCG · Device, Neurovascular Embolization · 111d
Cleared Jan 10, 2024
Zeta Cranial Navigation System (ZNS131-US)
K233903 · Zeta Surgical, Inc.
HAW · Neurological Stereotaxic Instrument · 30d
Cleared Jan 08, 2024
Electronic Muscle Stimulator (Model MP01)
K233035 · Shenzhen Hengbosi Industrial Co., Ltd.
NGX · Stimulator, Muscle, Powered, For Muscle Conditioning · 105d
Cleared Jan 07, 2024
autoSCORE
K231068 · Holberg Eeg AS
OMB · Automatic Event Detection Software For Full-montage Electroencephalograph · 268d
Cleared Jan 03, 2024
REMI AI Discrete Detection Module
K231779 · Epitel, Inc.
OMB · Automatic Event Detection Software For Full-montage Electroencephalograph · 201d
Cleared Dec 15, 2023
Ova+ (K-OVAP-USA)
K230926 · Tenscare, Ltd.
NUH · Stimulator, Nerve, Transcutaneous, Over-the-counter · 256d
Cleared Dec 08, 2023
NeuroBlate System
K231061 · Monteris Medical,
GEX · Powered Laser Surgical Instrument · 239d
Cleared Nov 27, 2023
ClearPoint System (Software Version 2.2)
K233243 · ClearPoint Neuro, Inc.
HAW · Neurological Stereotaxic Instrument · 60d
Cleared Nov 21, 2023
CranioXpand
K230211 · KLS-Martin L.P.
PBJ · Cranial Distraction System · 299d

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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 OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph 7