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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 Co., Ltd.
Product: Betters (Suzhou)Medical Co., Ltd. — all models and sizes
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 ?
510(k)
Number ?
K232241 ↗
Decision Date ?
November 13, 2023
Product Code ?
NEY System, Ablation, Microwave And Accessories
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.
FDA-Cleared Indications
- Ablation of soft-tissue tumors.
- Use in patients whose tumors can be accessed with the needle and for whom tumor ablation is clinically appropriate.
Clinical Applications
- Image-guided percutaneous ablation of accessible soft-tissue tumors.
- Microwave ablation performed in an interventional radiology suite or operating room.
- Use as part of a minimally invasive treatment plan when the treating clinician selects ablation instead of, or in addition to, other treatments such as surgery or medication.
Practical Considerations
- Available models include T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, and L-2018; model selection depends on needle length, active tip configuration, anatomy, and treatment target.
- The needle is intended for single use and must be used with a compatible microwave ablation generator and accessories according to the device labeling.
- Placement is generally performed with imaging guidance, such as ultrasound, computed tomography, or another suitable modality, depending on the target and clinical setting.
- Microwave ablation requires appropriate patient selection, assessment of nearby organs and critical structures, and clinician training in image-guided ablation.
- This is an active microwave-energy device rather than an MRI-only implant. MRI compatibility and any restrictions must be confirmed in the current manufacturer labeling; it should not be assumed to be safe during MRI.
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.