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
549 Neurology devices
Cleared
Jan 16, 2026
actiTENS mini
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
140d
Cleared
Jan 16, 2026
Toro 88 Superbore Catheter
QJP
Catheter, Percutaneous, Neurovasculature
177d
Not Cleared
Jan 16, 2026
Sana Device
QYN
Prescription Audiovisual Stimulator (avs) For Temporary Pain Relief (adjunctive Use)
319d
Cleared
Jan 15, 2026
Esperance pHLO Aspiration System
NRY
Catheter, Thrombus Retriever
260d
Cleared
Jan 14, 2026
METICULY Patient-specific titanium mesh implant
GXN
Plate, Cranioplasty, Preformed, Non-alterable
120d
Cleared
Jan 11, 2026
SafeOp 3: Neural Informatix System
GWF
Stimulator, Electrical, Evoked Response
125d
Cleared
Jan 07, 2026
Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides
PPT
Cranial Surgical Planning And Instrument Guides
100d
Cleared
Jan 06, 2026
V-DAC Catheter
QJP
Catheter, Percutaneous, Neurovasculature
271d
Cleared
Jan 05, 2026
SurfRider 13 Microcatheter
QJP
Catheter, Percutaneous, Neurovasculature
220d
Cleared
Jan 02, 2026
MONTAGE XT Cranial Cement
GXP
Methyl Methacrylate For Cranioplasty
30d
Cleared
Dec 31, 2025
TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
93d
Cleared
Dec 31, 2025
Genesis Sleep
QJQ
Cranial Electrotherapy Stimulator To Treat Insomnia And/or Anxiety
106d
Cleared
Dec 23, 2025
TENS&EMS (HZ9151B, HZ9151C, HZ9151D)
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
29d
Cleared
Dec 23, 2025
Sim&Size
PZO
Software For Visualization Of Vascular Anatomy And Intravascular Devices
89d
Cleared
Dec 23, 2025
Aura Glide (FC40)
NFO
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
162d
Cleared
Dec 23, 2025
Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209)
NFO
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
167d
Cleared
Dec 23, 2025
VEINOPLUS Back
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
181d
Cleared
Dec 22, 2025
EmbraceMini
LEL
Device, Sleep Assessment
96d
Cleared
Dec 14, 2025
Hypnos (369054-200)
OLZ
Automatic Event Detection Software For Polysomnograph With Electroencephalograph
268d
Cleared
Dec 11, 2025
Target Detachable Coil
HCG
Device, Neurovascular Embolization
107d
Cleared
Dec 10, 2025
Intellidrop
JXG
Shunt, Central Nervous System And Components
197d
Cleared
Dec 08, 2025
Ceribell Delirium Monitor System
NCG
Neuropsychiatric Interpretative Electroencephalograph Assessment Aid
167d
Cleared
Dec 03, 2025
Bendit17 Microcatheter
QJP
Catheter, Percutaneous, Neurovasculature
141d
Cleared
Dec 03, 2025
HippoMind (v1.0)
OLT
Non-normalizing Quantitative Electroencephalograph Software
168d
Cleared
Nov 28, 2025
Sophy Mini Monopressure Valve (SM1)
JXG
Shunt, Central Nervous System And Components
270d
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