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
May 22, 2023
TracStar LDP Large Distal Platform
QJP
Catheter, Percutaneous, Neurovasculature
27d
Cleared
May 13, 2023
HEATING TENS/EMS, FT-810R
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
197d
Cleared
Apr 20, 2023
STARband 3D
MVA
Orthosis, Cranial
182d
Cleared
Apr 19, 2023
Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial
HAW
Neurological Stereotaxic Instrument
145d
Cleared
Apr 11, 2023
Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set
NRY
Catheter, Thrombus Retriever
139d
Cleared
Mar 29, 2023
Trevo NXT ProVue Retriever
POL
Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
153d
Cleared
Mar 22, 2023
Ceribell Instant EEG Headcap
GXY
Electrode, Cutaneous
173d
Cleared
Mar 17, 2023
MagVenture TMS Atlas Neuro Navigation System
HAW
Neurological Stereotaxic Instrument
294d
Cleared
Mar 15, 2023
NeuroBlate Fusion-S Software V3.17
GEX
Powered Laser Surgical Instrument
168d
Cleared
Feb 22, 2023
Disposable Pre-calibrated Brain Biopsy Needle 2.0
HAW
Neurological Stereotaxic Instrument
28d
Cleared
Feb 16, 2023
Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Navigation Instruments, Mayfield Base with Articulating Arm, and Navigated Biopsy Needle, Electromagnetic Navigation Instruments, Precision Targeting System
HAW
Neurological Stereotaxic Instrument
582d
Cleared
Feb 10, 2023
TELIGEN System Peripheral Motor Nerve Stimulation Indications
PDQ
Neurosurgical Nerve Locator
88d
Cleared
Jan 24, 2023
Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1)
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
124d
Cleared
Jan 19, 2023
Disposable Non-invasive EEG Sensor
GXY
Electrode, Cutaneous
337d
Cleared
Jan 13, 2023
MONTAGE Settable, Resorbable Bone Putty
GXP
Methyl Methacrylate For Cranioplasty
196d
Cleared
Jan 10, 2023
ISAAC Neurovascular Navigation Catheter
DQY
Catheter, Percutaneous
176d
Cleared
Dec 21, 2022
AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
90d
Cleared
Dec 20, 2022
Penumbra System (Reperfusion Catheter RED 43)
NRY
Catheter, Thrombus Retriever
95d
Cleared
Dec 14, 2022
Target Tetra Detachable Coils
HCG
Device, Neurovascular Embolization
114d
Cleared
Nov 15, 2022
Everyway Analog OTC TENS
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
90d
Cleared
Nov 15, 2022
2.1 x 255mm Drill, 22mm Stop
HBE
Drills, Burrs, Trephines & Accessories (simple, Powered)
33d
Cleared
Nov 04, 2022
BENCHMARK BMX81 Access System
QJP
Catheter, Percutaneous, Neurovasculature
134d
Cleared
Oct 11, 2022
Branchor Balloon Guide Catheter
QJP
Catheter, Percutaneous, Neurovasculature
98d
Cleared
Sep 23, 2022
ATEC IOM Accessory Instruments
PDQ
Neurosurgical Nerve Locator
92d
Cleared
Sep 12, 2022
SOFIA 88 Catheter
DQY
Catheter, Percutaneous
264d
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