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
556 Neurology devices
Cleared
Sep 23, 2022
ATEC IOM Accessory Instruments
PDQ
Neurosurgical Nerve Locator
92d
Cleared
Sep 12, 2022
SOFIA 88 Catheter
DQY
Catheter, Percutaneous
264d
Cleared
Sep 08, 2022
Cranial EM System
HAW
Neurological Stereotaxic Instrument
262d
Cleared
Aug 18, 2022
Benchmark BMX96 Access System
QJP
Catheter, Percutaneous, Neurovasculature
307d
Cleared
Aug 17, 2022
Disposable Brain Biopsy Needle 2.0
HAW
Neurological Stereotaxic Instrument
142d
Cleared
Aug 04, 2022
Well-Life Mini TENS Stimulator(WL-23XXC/WL-23XXE Series)
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
162d
Cleared
Jul 22, 2022
BLUE 400
QFX
Diagnostic Neurosurgical Microscope Filter
445d
Cleared
Jul 14, 2022
CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini, and Freeform XtraSoft Detachable Coil Systems
HCG
Device, Neurovascular Embolization
190d
Cleared
Jun 10, 2022
Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4
HAW
Neurological Stereotaxic Instrument
58d
Cleared
Jun 03, 2022
KLS Martin Neuro Rongeurs
HAE
Rongeur, Manual
448d
Cleared
May 27, 2022
Benchmark Intracranial Access System
QJP
Catheter, Percutaneous, Neurovasculature
262d
Cleared
May 19, 2022
Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC)
HBC
Motor, Drill, Electric
91d
Cleared
Apr 21, 2022
GEMS-H
PHL
Powered Exoskeleton
177d
Cleared
Apr 19, 2022
Brainlab Elements Guide XT, Guide 3.0
QQC
Brain Stimulation Programming Planning Software.
124d
Cleared
Apr 12, 2022
PROWLER SELECT LP ES Microcatheter
KRA
Catheter, Continuous Flush
111d
Cleared
Mar 31, 2022
ERIC Retrieval Device
NRY
Catheter, Thrombus Retriever
350d
Cleared
Mar 24, 2022
FUBUKI XF Neurovascular Long Sheath
QJP
Catheter, Percutaneous, Neurovasculature
132d
Cleared
Mar 09, 2022
SafeOp 2: Neural Informatix System
GWF
Stimulator, Electrical, Evoked Response
89d
Cleared
Mar 04, 2022
BTL-995-rTMS
OBP
Transcranial Magnetic Stimulator
189d
Cleared
Feb 19, 2022
Well-Life TENS/EMS/Heating Stimulator
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
148d
Cleared
Jan 28, 2022
SyntheCel Dura Repair
GXQ
Dura Substitute
135d
Cleared
Jan 27, 2022
Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neuro Plating System-Packaging unit(NSP-001 and 10 models), Neuro Plating System-Sterile Kit(TCN-011 and 69 models), Neuro Plating System-Screws(N15A03 and 11 models)
GWO
Plate, Cranioplasty, Preformed, Alterable
353d
Cleared
Jan 21, 2022
Abbott Medical Grounding Pad, model RF-DGP-IS
GXD
Generator, Lesion, Radiofrequency
438d
Cleared
Jan 07, 2022
Visualase MRI-Guided Laser Ablation System (SW 3.4)
ONO
Neurosurgical Laser With Mr Thermography
255d
Cleared
Dec 29, 2021
CONVIVO In Vivo Pathology Suite
LLZ
System, Image Processing, Radiological
254d
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