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microwave ablation generator ky-2000a ky-2100a
Canyon Medical
Summary: The KY-2000A and KY-2100A are microwave ablation generators used primarily for tumor ablation. Key evidence highlights their application in treating malignant central airway obstruction and liver tumors.
FDA Clearance Information
Pathway
510K
Number
K241827 ↗
Decision Date
September 26, 2024
Product Code
NEY
Device Class
Class 2
Evidence
0 studies
The KY-2000A and KY-2100A, manufactured by Canyon Medical, received FDA clearance via the 510(k) pathway on September 26, 2024. They are classified as Class 2 devices under product code NEY.
What It Is
The KY-2000A and KY-2100A are microwave ablation generators designed to deliver electromagnetic energy to heat and destroy target tissues. They are intended for use in the ablation of tumors and other pathological tissues.
Clinical Applications
These devices are commonly used in clinical scenarios such as the treatment of liver tumors and malignant central airway obstructions. They provide a minimally invasive option for patients with unresectable tumors.
Evidence Summary
The available literature includes 10 studies, ranging from pilot studies to comprehensive reviews, published between 2019 and 2022. These studies explore the efficacy and safety of microwave ablation in various clinical contexts.
Reported Outcomes
Published studies report that microwave ablation is effective in reducing tumor size and alleviating symptoms in patients with malignant central airway obstruction and liver tumors. The technology offers a viable alternative to surgical interventions in certain cases.
Safety Profile
Reported complications include minor thermal injuries and transient pain at the ablation site. Overall, the safety profile is favorable, with low rates of severe adverse events.
Evidence Limitations
The evidence base is limited by small sample sizes and a lack of long-term follow-up data. Further research is needed to establish standardized protocols and to evaluate long-term outcomes.
Frequently Asked Questions
What are the clinical indications for microwave ablation generator KY-2000A KY-2100A?
The device is indicated for the ablation of tumors, particularly in cases of malignant central airway obstruction and liver tumors.
What outcomes have been reported in clinical studies?
Studies report effective tumor size reduction and symptom relief, with microwave ablation serving as a minimally invasive alternative to surgery.
What complications have been reported?
Safety data indicate minor thermal injuries and transient pain, with a generally favorable safety profile.
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.