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Microwave Ablation Device Exceed S10U Sterile Microwave Ablation Probe Exact
Hygea Medical Technology Co., Ltd.
Product: Hygea — all models and sizes
Summary: The Exceed S10U is a sterile microwave ablation probe used for tumor ablation. It is FDA 510k cleared and linked to two studies, though specific clinical outcomes and safety data are not detailed in the provided evidence.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K233140 ↗
Decision Date ?
January 31, 2024
Product Code ?
NEY System, Ablation, Microwave And Accessories
Device Class ?
Class 2
Evidence ?
0 studies
The Exceed S10U, manufactured by Hygea Medical Technology, received FDA 510k clearance on January 31, 2024. It is classified as a Class 2 device under product code NEY.
What It Is
The Exceed S10U is a microwave ablation device designed for the ablation of tumors. It uses microwave energy to generate heat, causing coagulative necrosis in targeted tissues. This device is intended for use in minimally invasive procedures.
FDA-Cleared Indications
- For use in microwave ablation procedures to coagulate and destroy targeted tissue.
- For use in the ablation of tumors when used with compatible microwave ablation equipment.
- For use as a sterile, single-use microwave ablation probe in minimally invasive procedures.
Clinical Applications
- Percutaneous microwave ablation of selected tumors under imaging guidance.
- Microwave ablation performed by inserting the probe into a targeted tumor to produce coagulative necrosis.
- Minimally invasive tumor treatment when ablation is selected instead of, or as an alternative to, surgical resection.
- Tumor ablation procedures performed with compatible microwave generators and accessories.
Evidence Summary
The available literature includes two studies, though neither directly evaluates the Exceed S10U. The studies span from 1995 to 2025, with one focusing on a different technology and the other on benign prostatic hyperplasia.
Reported Outcomes
Published studies report no specific efficacy findings related to the Exceed S10U. The provided evidence does not include direct outcomes from clinical use of this device.
Safety Profile
Reported complications include no specific safety data related to the Exceed S10U. The evidence provided does not detail adverse events or complications from its use.
Evidence Limitations
The evidence lacks direct clinical studies evaluating the Exceed S10U, highlighting a gap in specific efficacy and safety data. Further research is needed to establish comprehensive clinical outcomes and safety profiles.
Practical Considerations
- The available record does not provide the probe diameter, active-tip lengths, shaft lengths, generator compatibility details, or approved power settings; these should be confirmed in the device labeling before use.
- The probe is sterile and intended for single use; follow the manufacturer’s instructions for handling, insertion, connection, activation, and disposal.
- Microwave ablation requires compatible equipment and imaging guidance, commonly ultrasound, computed tomography, or another modality appropriate for the target.
- MRI compatibility is not established in the provided record. Do not use the probe in or near an MRI environment unless the labeling specifically identifies it as MR Safe or MR Conditional.
- Patient selection, treatment margins, nearby organs and vessels, bleeding risk, infection risk, and heat injury to adjacent structures should be evaluated before the procedure.
Frequently Asked Questions
What are the clinical indications for microwave ablation device exceed s10u?
The device is indicated for tumor ablation, utilizing microwave energy to achieve tissue necrosis.
What outcomes have been reported in clinical studies?
The provided evidence does not include specific outcomes related to the Exceed S10U.
What complications have been reported?
No specific complications related to the Exceed S10U are detailed in the provided evidence.
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.