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
4702 Neurology devices
Cleared
Oct 28, 2020
NIM Vital, Nerve Integrity Monitor
GWF
Stimulator, Electrical, Evoked Response
218d
Cleared
Oct 24, 2020
Li-Battery powered OTC TENS/EMS Combination Stimulator
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
157d
Cleared
Oct 23, 2020
Nerivio
QGT
Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine
114d
Cleared
Oct 21, 2020
IonicRF Generator
GXD
Generator, Lesion, Radiofrequency
128d
Cleared
Oct 19, 2020
Transcutaneous Electronic Nerve Stimulator
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
269d
Cleared
Oct 08, 2020
Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software ENT, Registration Software Cranial, Automatic Registration 2.0, Ultrasound Navigation Software (BK), Intraoperative Structure Update
HAW
Neurological Stereotaxic Instrument
377d
Cleared
Oct 08, 2020
Portable Electro-Stimulation Therapy Device, Model: LGT-232(US)
NGX
Stimulator, Muscle, Powered, For Muscle Conditioning
94d
Cleared
Oct 02, 2020
HAL for Medical Use(Lower Limb type)
PHL
Powered Exoskeleton
114d
Cleared
Sep 30, 2020
Tua Face Fitness / Tua Trend Face
NFO
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
425d
Cleared
Sep 29, 2020
Cadwell Apollo System
GWQ
Full-montage Standard Electroencephalograph
90d
Cleared
Sep 29, 2020
Cefaly Dual
PCC
Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
83d
Cleared
Sep 28, 2020
RIST Radial Access Catheter
QJP
Catheter, Percutaneous, Neurovasculature
98d
Cleared
Sep 25, 2020
Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-2222, KTR-2212)
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
428d
Cleared
Sep 25, 2020
Synchro SELECT Guidewire
MOF
Guide, Wire, Catheter, Neurovasculature
24d
Cleared
Sep 23, 2020
Nerve and Muscle Stimulator
GZI
Stimulator, Neuromuscular, External Functional
302d
Cleared
Sep 18, 2020
DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional
GXN
Plate, Cranioplasty, Preformed, Non-alterable
357d
Cleared
Sep 14, 2020
VersaWrap Nerve Protector
JXI
Cuff, Nerve
90d
Cleared
Sep 14, 2020
Marathon Flow Directed Micro Catheter
KRA
Catheter, Continuous Flush
28d
Cleared
Sep 09, 2020
Keeogo Dermoskeleton System
PHL
Powered Exoskeleton
92d
Cleared
Sep 06, 2020
EyeBOX
QEA
Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid
66d
Cleared
Sep 04, 2020
MSLS6QF TENS/PMS Device
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
249d
Cleared
Sep 02, 2020
ZOOM (71, 55, 45, 35) Reperfusion Catheters
NRY
Catheter, Thrombus Retriever
29d
Cleared
Aug 31, 2020
KLS Martin Individual Patient Solutions (IPS) Planning System
PPT
Cranial Surgical Planning And Instrument Guides
132d
Cleared
Aug 31, 2020
Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology
NRY
Catheter, Thrombus Retriever
21d
Cleared
Aug 28, 2020
FitRelief TENS&EMS Wireless Device
NGX
Stimulator, Muscle, Powered, For Muscle Conditioning
406d
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