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avecure bt microwave ablation system
Medwaves
Summary: The Avecure BT Microwave Ablation System is a medical device used for the ablation of tumors. It is primarily utilized by interventional radiologists and oncologists to treat patients with certain types of tumors.
FDA Clearance Information
Pathway 510K
Number K192406 ↗
Decision Date November 25, 2020
Product Code NEY
Device Class Class 2
Evidence 0 studies
The Avecure BT Microwave Ablation System was cleared through the FDA 510k pathway on November 25, 2020. Manufactured by Medwaves, it is classified as a Class 2 device under product code NEY.
What It Is
The Avecure BT Microwave Ablation System is a device that uses microwave energy to generate heat, which is then applied to tissue to destroy tumor cells. It is designed for precise targeting and efficient ablation of tumors, offering a minimally invasive option for patients. The system typically consists of a microwave generator, applicator, and cooling system to ensure controlled and effective treatment.
Clinical Applications
This device is commonly used in the treatment of liver, lung, and kidney tumors. It is often employed in interventional radiology suites and oncology departments. The system is suitable for patients who are not candidates for surgical resection or who prefer a less invasive approach. It is particularly useful in treating tumors that are difficult to access or located near critical structures.
Indications for Use
The FDA-cleared indications for the Avecure BT Microwave Ablation System include the ablation of soft tissue tumors. It is intended for patients with tumors that are amenable to microwave ablation, offering an alternative to surgical intervention.
Practical Considerations
The device is available in various sizes to accommodate different tumor sizes and locations. It is compatible with standard imaging guidance systems, which aids in precise placement and monitoring during procedures. Clinicians should be trained in microwave ablation techniques to optimize outcomes.
Frequently Asked Questions
What is the Avecure BT Microwave Ablation System used for?
It is used for the ablation of tumors in soft tissues, such as the liver, lung, and kidney.
What specialties typically use this device?
Interventional radiologists and oncologists typically use this device in clinical settings.
What are the FDA-cleared indications?
The device is indicated for the ablation of soft tissue tumors, providing a minimally invasive treatment option.
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.