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
6334
Total
6279
Cleared
155d
Avg (2y)
1976
Since
6334 Neurology devices
Cleared
May 22, 2015
Stryker Maestro Air Motors
HBB
Motor, Drill, Pneumatic
57d
Cleared
May 19, 2015
RETeval Visual Electrodiagnostic Device
GWE
Stimulator, Photic, Evoked Response
249d
Cleared
May 15, 2015
ANSISTIM
BWK
Stimulator, Electro-acupuncture
374d
Cleared
May 15, 2015
CLINISCANSM EEG
OMB
Automatic Event Detection Software For Full-montage Electroencephalograph
308d
Cleared
May 15, 2015
Brainscope Ahead 200
PIW
Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid
144d
Cleared
May 12, 2015
GEMORE OTC TENS
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
56d
Cleared
May 08, 2015
Stryker Footed Attachments and Cutting Accessories
HBE
Drills, Burrs, Trephines & Accessories (simple, Powered)
161d
Cleared
May 08, 2015
Rapid Therapy System
OBP
Transcranial Magnetic Stimulator
147d
Cleared
May 01, 2015
Stryker MIS Attachments and Cutting Accessories
HBE
Drills, Burrs, Trephines & Accessories (simple, Powered)
137d
Cleared
Apr 24, 2015
Neuromaster G1 MEE200
GWF
Stimulator, Electrical, Evoked Response
220d
Cleared
Apr 23, 2015
STARBAND, STARLIGHT
OAN
Orthosis, Cranial, Laser Scan
261d
Cleared
Apr 23, 2015
Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments
HBE
Drills, Burrs, Trephines & Accessories (simple, Powered)
155d
Cleared
Apr 20, 2015
Natus Quantum
GWQ
Full-montage Standard Electroencephalograph
139d
Cleared
Apr 16, 2015
BIS STANDARD SENSOR,1-CHANNEL (3 ELECTRODES)
GXY
Electrode, Cutaneous
127d
Cleared
Apr 16, 2015
Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles (TM)-Redmons (TM) Kerrison Rongeurs, Integra (R) Miltex (R) Kerrison Rongeurs, Integra (R) Meisterhand (R) Kerrison Rongeurs
HAE
Rongeur, Manual
56d
Cleared
Apr 16, 2015
Alcyone MEMS Cannula (AMC) System
HCD
Cannula, Ventricular
34d
Cleared
Apr 13, 2015
MDT Navigable Brain Biopsy Cannula
HAW
Neurological Stereotaxic Instrument
152d
Cleared
Apr 06, 2015
Trevo XP ProVue Retriever (6X25mm)
NRY
Catheter, Thrombus Retriever
161d
Cleared
Apr 02, 2015
POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM/POLARIS ADJUSTABLE VALVE WITH SIPHONX
JXG
Shunt, Central Nervous System And Components
325d
Cleared
Apr 02, 2015
AESCULAP - MEITHKE PROGAV 2.0 ADJUSTABLE SHUNT SYSTEM
JXG
Shunt, Central Nervous System And Components
294d
Cleared
Apr 02, 2015
MYGAIT STIMULATION SYSTEM
GZI
Stimulator, Neuromuscular, External Functional
269d
Cleared
Apr 02, 2015
BRIGHTMATTER NAVIGATION SYSTEM
HAW
Neurological Stereotaxic Instrument
251d
Cleared
Mar 27, 2015
DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS)
HBW
Fastener, Plate, Cranioplasty
304d
Cleared
Mar 27, 2015
NuVasive NVM5 System
PDQ
Neurosurgical Nerve Locator
95d
Cleared
Mar 25, 2015
STYLET, 23CM, SKULL-MOUNT PATIENT TRACKER, NON-INVASIVE PATIENT TRACKER, TRACER POINTER, TOUCH-N-GO POINTER, NAVIGATION
HAW
Neurological Stereotaxic Instrument
261d
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