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
Dec 10, 2021
Branchor Balloon Guide Catheter
QJP
Catheter, Percutaneous, Neurovasculature
354d
Cleared
Dec 05, 2021
INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor)
MUD
Oximeter, Tissue Saturation
199d
Cleared
Nov 26, 2021
Trevo Trak 21 Microcatheter
QJP
Catheter, Percutaneous, Neurovasculature
186d
Cleared
Nov 16, 2021
InZone Detachment System
HCG
Device, Neurovascular Embolization
103d
Cleared
Nov 12, 2021
Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic Alignment Module, Cirq Robotic Alignment Cranial And Spine, CIRQ Robotic Alignment Cranial and Spine System
HAW
Neurological Stereotaxic Instrument
224d
Cleared
Nov 03, 2021
Trajectory Planning, Elements Trajectory Planning, Elements Lead Localization
HAW
Neurological Stereotaxic Instrument
168d
Cleared
Oct 22, 2021
P300 Attachment
HBE
Drills, Burrs, Trephines & Accessories (simple, Powered)
449d
Cleared
Sep 16, 2021
StrataMR II Valves and Shunts
JXG
Shunt, Central Nervous System And Components
27d
Cleared
Aug 27, 2021
AXS Vecta 46 Intermediate Catheter
QJP
Catheter, Percutaneous, Neurovasculature
340d
Cleared
Aug 27, 2021
Trevo NXT ProVue Retriever
POL
Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
186d
Cleared
Aug 25, 2021
PROWLER SELECT PLUS
KRA
Catheter, Continuous Flush
156d
Cleared
Aug 24, 2021
ELAN 4 Electro Motor System
HBE
Drills, Burrs, Trephines & Accessories (simple, Powered)
245d
Cleared
Aug 17, 2021
STARband
OAN
Orthosis, Cranial, Laser Scan
105d
Cleared
Aug 16, 2021
Penumbra System (Reperfusion Catheter RED 72)
NRY
Catheter, Thrombus Retriever
80d
Cleared
Aug 06, 2021
1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S 4K Sinuscopes
GWG
Endoscope, Neurological
106d
Cleared
Jul 27, 2021
Rist 071 Radial Access Guide Catheter
DQY
Catheter, Percutaneous
29d
Cleared
Jul 07, 2021
Axium Detachable Coil
HCG
Device, Neurovascular Embolization
226d
Cleared
Jul 01, 2021
Penumbra System (RED 68 Reperfusion Catheter)
NRY
Catheter, Thrombus Retriever
56d
Cleared
Jun 30, 2021
Stryker iBur hubs and cutting accessories
HBE
Drills, Burrs, Trephines & Accessories (simple, Powered)
141d
Cleared
Jun 17, 2021
Migraine Tens Digital Pain Reliever
PCC
Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
129d
Cleared
Jun 01, 2021
Well-Life Garment Electrodes (GM Series)
GXY
Electrode, Cutaneous
419d
Cleared
May 28, 2021
MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini Microcoil Delivery Systems
HCG
Device, Neurovascular Embolization
25d
Cleared
May 20, 2021
Penumbra System (Reperfusion Catheter RED 62)
NRY
Catheter, Thrombus Retriever
178d
Cleared
Apr 27, 2021
STARband, STARlight, St. Louis Band
OAN
Orthosis, Cranial, Laser Scan
195d
Cleared
Mar 01, 2021
Solitaire X Revascularization Device
POL
Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
105d
Looking for a specific neurology device? Search by device name, K-number or manufacturer.
Search all Neurology 510(k) devices