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auragen cortical surface electrodes
Integra Neurosciences
Summary: The auragen cortical surface electrodes are used for neurosurgical procedures, particularly in brain mapping and monitoring electrical activity. They are primarily used by neurosurgeons and neurologists.
FDA Clearance Information
Pathway
510K
Number
K082250 ↗
Decision Date
October 10, 2008
Product Code
GYC
Device Class
Class 2
Evidence
0 studies
The auragen cortical surface electrodes were cleared through the FDA 510(k) pathway on October 10, 2008, by Integra Neurosciences. It is a Class 2 medical device under product code GYC.
What It Is
The auragen cortical surface electrodes are medical devices designed to be placed on the cortical surface of the brain. They are used to detect and record electrical activity from the cerebral cortex. These electrodes are crucial in procedures that require brain mapping, such as epilepsy surgery, where precise localization of functional and dysfunctional brain areas is necessary.
Clinical Applications
These electrodes are commonly used in neurosurgical settings, particularly during epilepsy surgery and other procedures requiring cortical mapping. They help in identifying functional areas of the brain to avoid during surgical resection. The device is used by neurosurgeons and neurologists, often in hospital operating rooms or specialized epilepsy centers, and is crucial for patients undergoing evaluation for surgical treatment of epilepsy.
Indications for Use
The FDA indications suggest that the device is intended for use in patients requiring brain mapping, such as those with epilepsy or brain tumors. It helps in identifying areas of the brain responsible for critical functions to guide surgical interventions.
Practical Considerations
These electrodes come in various sizes to accommodate different cortical surfaces and are compatible with standard monitoring equipment. Proper placement and secure attachment are crucial for accurate readings, and care should be taken to avoid damage to the cortical surface during application.
Frequently Asked Questions
What is auragen cortical surface electrodes used for?
They are used for detecting and recording electrical activity from the brain's surface, particularly in brain mapping for epilepsy surgery.
What specialties typically use this device?
Neurosurgeons and neurologists, especially those specializing in epilepsy and brain tumor surgeries, typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in brain mapping and monitoring electrical activity in patients undergoing neurosurgical procedures, such as those with epilepsy or brain tumors.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.