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cryoice cryoxt cryoablation probe cryoxt
Atricure
Summary: The Cryoice CryoXT Cryoablation Probe by AtriCure is a medical device used for cryoablation procedures to treat tumors. It is primarily used by surgeons and interventional radiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K250371 ↗
Decision Date
April 10, 2025
Product Code
GXH
Device Class
Class 2
Evidence
0 studies
The Cryoice CryoXT Cryoablation Probe received FDA 510k clearance (K250371) on April 10, 2025. Manufactured by AtriCure, it is classified as a Class 2 medical device under product code GXH.
What It Is
The Cryoice CryoXT Cryoablation Probe is a specialized device designed for cryoablation, a technique that uses extreme cold to destroy abnormal tissue, such as tumors. It operates by delivering cryogenic temperatures to targeted areas, effectively inducing cell death in the tissue. This device is particularly useful in minimally invasive procedures, offering precision and control in ablation therapy.
Clinical Applications
This device is commonly used in surgical oncology and interventional radiology for the treatment of solid tumors. It is particularly beneficial in scenarios where traditional surgical resection is challenging or when preserving surrounding healthy tissue is critical. Typical settings include operating rooms and specialized cancer treatment centers, with patient populations ranging from those with primary tumors to those with metastatic disease.
Indications for Use
The FDA has cleared this device for the ablation of tumors, meaning it is intended for patients with solid tumors that require precise and controlled destruction. It is suitable for use in patients where other forms of treatment may not be viable or effective.
Practical Considerations
The Cryoice CryoXT Cryoablation Probe is designed to be compatible with standard cryoablation systems. Clinicians should consider the probe's size and reach when planning procedures, ensuring it is suitable for the targeted anatomical area. Proper technique and familiarity with cryoablation are essential for optimal outcomes.
Frequently Asked Questions
What is Cryoice CryoXT Cryoablation Probe used for?
It is used for the cryoablation of tumors, employing extreme cold to destroy abnormal tissue.
What specialties typically use this device?
This device is typically used by surgical oncologists and interventional radiologists.
What are the FDA-cleared indications?
The device is cleared for the ablation of tumors, targeting patients with solid tumors requiring precise tissue destruction.
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.