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sunspots pre-gelled surface electrodes
Axon Systems
Summary: Sunspots pre-gelled surface electrodes are used in tumor ablation procedures. They are typically utilized by clinicians in oncology and surgical settings to deliver precise electrical stimulation.
FDA Clearance Information
Pathway
510K
Number
K062198 ↗
Decision Date
December 19, 2006
Product Code
GXY
Device Class
Class 2
Evidence
0 studies
The sunspots pre-gelled surface electrodes by Axon Systems were cleared through the FDA 510k pathway on December 19, 2006. This device is classified as a Class 2 medical device.
What It Is
Sunspots pre-gelled surface electrodes are medical devices designed to deliver electrical stimulation to targeted areas during tumor ablation procedures. These electrodes are pre-gelled, which facilitates better contact with the skin and ensures consistent electrical conduction. Their design allows for precise application, which is crucial in ablation therapies to minimize damage to surrounding healthy tissues.
Clinical Applications
These electrodes are commonly used in oncology settings for tumor ablation procedures, where precise electrical stimulation is required to destroy cancerous tissues. They are typically employed in surgical environments by oncologists and surgeons specializing in minimally invasive procedures. The device is suitable for adult patients undergoing treatment for various types of tumors.
Indications for Use
The FDA indications suggest that these electrodes are intended for use in procedures that require electrical stimulation for tumor ablation. They are particularly useful in cases where precise targeting of tumor tissues is necessary to ensure effective treatment while sparing healthy tissue.
Practical Considerations
Sunspots electrodes are available in various sizes to accommodate different patient needs and anatomical locations. They are compatible with standard ablation equipment and require minimal preparation due to their pre-gelled nature. Clinicians should ensure proper placement to maximize efficacy and minimize discomfort.
Frequently Asked Questions
What is sunspots pre-gelled surface electrodes used for?
They are used for delivering electrical stimulation in tumor ablation procedures.
What specialties typically use this device?
Oncology and surgical specialties, particularly those involved in tumor ablation procedures.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring electrical stimulation for tumor ablation.
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.