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disposable microwave ablation needle t-1408 t-1410 t-1608 t-1610 l-1815 l-1818 l-2015 l-2018
Betters(Suzhou) Medical
Summary: The disposable microwave ablation needle is a medical device used for the ablation of soft tissue tumors. It is typically used by interventional radiologists and oncologists in hospital settings.
FDA Clearance Information
Pathway 510K
Number K232241 ↗
Decision Date November 13, 2023
Product Code NEY
Device Class Class 2
Evidence 0 studies
This device was cleared through the FDA 510(k) pathway on November 13, 2023. Manufactured by Betters(Suzhou) Medical, it is classified as a Class 2 device under product code NEY.
What It Is
The disposable microwave ablation needle is a minimally invasive device designed to ablate soft tissue tumors using microwave energy. It works by delivering high-frequency electromagnetic waves that generate heat, causing coagulative necrosis of the targeted tissue. This technique is beneficial for precise tumor targeting and minimal damage to surrounding tissues.
Clinical Applications
Commonly used in interventional radiology and oncology, this device is employed in procedures for treating liver, lung, kidney, and bone tumors. It is suitable for patients who are not candidates for surgical resection or those seeking a less invasive treatment option. The device is typically used in hospital settings, including operating rooms and specialized radiology suites.
Indications for Use
The FDA-cleared indications for this device include the ablation of soft tissue tumors. It is intended for patients with tumors that are accessible by percutaneous approaches and where ablation is deemed appropriate by the treating clinician.
Practical Considerations
The device comes in various sizes, such as T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, and L-2018, to accommodate different tumor sizes and locations. It is compatible with standard microwave ablation systems. Clinicians should be trained in microwave ablation techniques to ensure optimal outcomes.
Frequently Asked Questions
What is the disposable microwave ablation needle used for?
It is used for the ablation of soft tissue tumors in various organs such as the liver, lungs, kidneys, and bones.
What specialties typically use this device?
Interventional radiologists and oncologists typically use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for the ablation of soft tissue tumors, suitable for patients where percutaneous ablation is appropriate.
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.