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
Cleared
Aug 12, 2024
Pixie Pulse (SM9068)
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
90d
Cleared
Aug 07, 2024
SofWave System
NGX
Stimulator, Muscle, Powered, For Muscle Conditioning
57d
Cleared
Aug 05, 2024
Sleepio®
QVO
Computerized Behavioral Therapy Device For Insomnia
272d
Cleared
Aug 01, 2024
A Breathing System (ABS)
HCC
Device, Biofeedback
268d
Cleared
Jul 31, 2024
EARP Nerve Cuff Electrode
ETN
Stimulator, Nerve
30d
Cleared
Jul 26, 2024
DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00)
HBL
Holder, Head, Neurosurgical (skull Clamp)
28d
Cleared
Jul 22, 2024
Transcutaneous Electrical Nerve Stimulator (K6106)
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
90d
Cleared
Jul 19, 2024
Wireless TENS & EMS (Model SM9110,SM9113,SM9116)
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
297d
Cleared
Jul 18, 2024
CEFALY Connected - OTC, CEFALY Connected - Rx
PCC
Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
211d
Cleared
Jul 18, 2024
B4C System - Addition of new sensor model (BcSs-PICNIW-2000)
GWM
Device, Monitoring, Intracranial Pressure
115d
Not Cleared
Jul 16, 2024
allay Nerve Cap
SBG
In Situ Polymerizing Peripheral Nerve Cap
308d
Cleared
Jul 11, 2024
Drivewire 24 Guidewire
MOF
Guide, Wire, Catheter, Neurovasculature
226d
Cleared
Jul 02, 2024
Next Generation Access Catheter
QJP
Catheter, Percutaneous, Neurovasculature
193d
Cleared
Jul 02, 2024
Next Generation Aspiration Catheter
NRY
Catheter, Thrombus Retriever
193d
Cleared
Jun 28, 2024
BLUE 400
QFX
Diagnostic Neurosurgical Microscope Filter
154d
Cleared
Jun 27, 2024
NuFACE® FIX+
NFO
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
119d
Cleared
Jun 27, 2024
TENS&EMS units (SM9109A, SM9109B)
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
30d
Cleared
Jun 21, 2024
Mochida Nerve Cuff
JXI
Cuff, Nerve
266d
Cleared
Jun 20, 2024
Freedom Peripheral Nerve Stimulator (PNS) System
GZF
Stimulator, Peripheral Nerve, Implanted (pain Relief)
267d
Cleared
Jun 17, 2024
VERABAND™
LEL
Device, Sleep Assessment
182d
Cleared
Jun 14, 2024
EndeavorOTC
QFT
Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder
228d
Cleared
Jun 11, 2024
DOOPANG
PCC
Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
277d
Cleared
Jun 06, 2024
TracStar LDP Large Distal Platform
QJP
Catheter, Percutaneous, Neurovasculature
59d
Cleared
Jun 04, 2024
Monteris Medical NeuroBlate System
ONO
Neurosurgical Laser With Mr Thermography
67d
Cleared
Jun 03, 2024
Milieve (YPS-301BD)
PCC
Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
194d
Looking for a specific neurology device? Search by device name, K-number or manufacturer.
Search all Neurology 510(k) devices