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Atricure
Summary: The CryoICE Cryosphere Cryoablation Probe is a medical device used for cryoablation procedures to treat tumors. It is typically used by surgeons and interventional radiologists in various clinical settings.
FDA Clearance Information
Pathway
510K
Number
K233170 ↗
Decision Date
October 26, 2023
Product Code
GXH
Device Class
Class 2
Evidence
0 studies
The CryoICE Cryosphere Cryoablation Probe by AtriCure was cleared through the FDA 510(k) pathway on October 26, 2023. It is classified as a Class 2 medical device.
What It Is
The CryoICE Cryosphere Cryoablation Probe is a specialized device designed for cryoablation, a process that uses extreme cold to destroy abnormal tissues, such as tumors. The device operates by delivering controlled cryogenic temperatures to targeted areas, effectively inducing cell death in the treated tissues. This minimally invasive technology is particularly useful in precise ablation procedures.
Clinical Applications
The CryoICE Cryosphere is commonly used in surgical oncology and interventional radiology for the treatment of various tumors. It is suitable for use in both hospital and outpatient settings, allowing for targeted ablation of tumors in patients who may not be candidates for traditional surgery. The device is particularly beneficial for patients with localized tumors where precision is crucial.
Indications for Use
The FDA-cleared indications for the CryoICE Cryosphere include the ablation of tumors. This means it is intended for use in patients who require destruction of tumor tissue, often in cases where surgical resection is not feasible or as an adjunct to other therapies.
Practical Considerations
The CryoICE Cryosphere probes come in various sizes to accommodate different procedural needs and anatomical locations. It is important to ensure compatibility with existing cryoablation systems and to follow specific technique guidelines for optimal results. Clinicians should be trained in cryoablation techniques to maximize safety and efficacy.
Frequently Asked Questions
What is the CryoICE Cryosphere used for?
The CryoICE Cryosphere is used for cryoablation procedures to destroy tumor tissues using extreme cold.
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, meaning it is used to destroy tumor tissues.
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.