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daehan adhesive surface electrodes
Daehan Medical Systems
Summary: Daehan Adhesive Surface Electrodes are used in tumor ablation procedures. They are typically utilized by oncologists and surgeons in clinical settings for precise tumor targeting.
FDA Clearance Information
Pathway
510K
Number
K180247 ↗
Decision Date
November 1, 2018
Product Code
GXY
Device Class
Class 2
Evidence
0 studies
The Daehan Adhesive Surface Electrodes were cleared through the FDA 510(k) pathway on November 1, 2018. Manufactured by Daehan Medical Systems, this Class 2 device is categorized under product code GXY.
What It Is
Daehan Adhesive Surface Electrodes are medical devices designed to deliver electrical currents to targeted tissue areas, primarily for tumor ablation. They work by adhering to the skin surface, allowing for non-invasive or minimally invasive procedures. These electrodes are crucial in ensuring precise delivery of energy, minimizing damage to surrounding healthy tissues.
Clinical Applications
These electrodes are commonly used in oncology for the ablation of tumors, particularly in cases where surgical resection is not feasible. They are employed in both hospital and outpatient settings, often in conjunction with imaging technologies to guide placement and ensure accuracy. Patients with liver, lung, or kidney tumors may benefit from procedures using these electrodes.
Indications for Use
The FDA indications suggest that these electrodes are intended for use in procedures aimed at destroying tumor cells. They are suitable for patients with specific types of tumors where ablation is deemed appropriate by the treating physician.
Practical Considerations
Daehan Adhesive Surface Electrodes come in various sizes to accommodate different anatomical locations and tumor sizes. They are compatible with standard ablation generators. Proper skin preparation is essential to ensure effective adhesion and energy transfer.
Frequently Asked Questions
What is Daehan Adhesive Surface Electrodes used for?
They are used for tumor ablation procedures, delivering electrical currents to destroy tumor cells.
What specialties typically use this device?
Oncologists and surgeons, particularly those specializing in interventional oncology, frequently use these electrodes.
What are the FDA-cleared indications?
They are indicated for use in tumor ablation procedures, targeting specific tumor types for destruction.
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.