Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-II14, DW-XR-II5, DW-XR-II6, DW-XR-II7, DW-XR-II8, DW-XR-II9, DW-XR-II10, DW-XR-II18, DW-XR-II19, DW-XR-II20, DW-XR-II21, DW-DG-II6, DW-DG-II7, DW-DG-II9, DW-DG-II10, DW-DG-II13)

FDA-Cleared Indications

• Used with a compatible microwave ablation system to coagulate or ablate soft tissue during open, laparoscopic, or percutaneous procedures.
• Intended for the ablation of tissue, including malignant or benign tumors, when used with the specified microwave ablation generator and according to the device labeling.
• The device is classified under product code NEY for microwave ablation systems and accessories.

Clinical Applications

• Percutaneous microwave ablation of selected liver tumors under ultrasound, CT, or other appropriate imaging guidance.
• Microwave ablation of selected kidney tumors under image guidance.
• Laparoscopic or open microwave ablation of accessible soft-tissue lesions when clinically indicated.
• Delivery of controlled microwave energy through an antenna connected to a compatible microwave ablation generator.

Reported off-label uses

• Microwave ablation of selected tumors in other organs, such as the lung, adrenal gland, bone, or thyroid, has been described for this device category but may be outside the specific labeling for these antenna models.

Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.

Practical Considerations

• The device is disposable and intended for single use; do not reuse, reprocess, or resterilize unless the labeling specifically permits it.
• The DW-XR and DW-DG model families include different antenna configurations and sizes. Confirm the selected model, active tip length, shaft dimensions, and intended access route before the procedure.
• Use only with a compatible microwave ablation generator and accessories. Follow the generator, antenna, grounding, power, and treatment-time instructions provided in the labeling.
• MRI compatibility should not be assumed. The antenna and connected equipment may contain conductive or metallic components and should not be used in the MRI environment unless the complete system is specifically labeled MR Safe or MR Conditional.
• Avoid use when the patient cannot safely undergo the planned procedure or anesthesia, when the target cannot be accessed safely, or when nearby critical structures cannot be protected from thermal injury, bleeding, or other procedural complications.