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microwave ablation device exceed s10u sterile microwave ablation probe exact
Hygea Medical Technology
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 510K
Number K233140 ↗
Decision Date January 31, 2024
Product Code NEY
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.
Clinical Applications
Commonly used in the treatment of tumors, the Exceed S10U is applied in scenarios where precise ablation is required. It is particularly useful in cases where traditional surgical methods are not feasible or desirable.
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.
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.