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microwave ablation system
Surgnova Healthcare Technologies (Zhejiang)
Summary: The Surgnova microwave ablation system is used for tumor ablation, particularly in liver and thyroid cases. Key evidence highlights its efficacy and safety in stereotactic and overlapping ablation techniques.
FDA Clearance Information
Pathway 510K
Number K183153 ↗
Decision Date July 8, 2019
Product Code NEY
Device Class Class 2
Evidence 0 studies
The Surgnova microwave ablation system was cleared by the FDA via the 510(k) pathway on July 8, 2019. It is manufactured by Surgnova Healthcare Technologies and classified as a Class 2 device.
What It Is
The microwave ablation system by Surgnova is designed for the thermal ablation of tumors using microwave energy. It is intended for use in the treatment of primary and secondary liver tumors, as well as benign thyroid nodules.
Clinical Applications
Commonly used in the ablation of liver tumors and benign thyroid nodules, the device is employed in both curative and palliative settings. It is particularly useful in cases where surgical resection is not feasible.
Evidence Summary
The literature includes 15 studies ranging from 2020 to 2025, encompassing various study designs such as RCTs and observational studies. These studies collectively evaluate the device's efficacy and safety.
Reported Outcomes
Published studies report that the microwave ablation system achieves high primary technique efficacy in liver tumor ablation. The device is noted for its precise ablation zone prediction and effective temperature distribution, contributing to successful tumor ablation.
Safety Profile
Reported complications include minor procedural complications, with no significant adverse events noted in the majority of studies. The device's safety profile is generally favorable, with low incidence of severe complications.
Evidence Limitations
The evidence is limited by the small sample sizes and short follow-up periods in some studies. Further research is needed to evaluate long-term outcomes and to compare the device's performance with other ablation technologies.
Frequently Asked Questions
What are the clinical indications for the microwave ablation system?
The device is indicated for the ablation of primary and secondary liver tumors and benign thyroid nodules.
What outcomes have been reported in clinical studies?
Studies report high efficacy in achieving complete tumor ablation with precise control over ablation zones.
What complications have been reported?
Safety data indicate minor procedural complications, with a low incidence of severe adverse events.
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.