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bio-probe disposable insert with balance biosurface carmeda bioactive surface trillium biosurface
Medtronic
Summary: The bio-probe disposable insert by Medtronic is a medical device used in tumor ablation procedures. It is typically utilized by oncologists and interventional radiologists to treat patients with certain types of tumors.
FDA Clearance Information
Pathway
510K
Number
K132730 ↗
Decision Date
May 30, 2014
Product Code
DPT
Device Class
Class 2
Evidence
0 studies
The bio-probe disposable insert was cleared through the FDA 510(k) pathway on May 30, 2014. It is manufactured by Medtronic and classified as a Class 2 device under product code DPT.
What It Is
The bio-probe disposable insert is a specialized medical device designed for use in tumor ablation procedures. It features a balance biosurface with a Carmeda bioactive surface and a Trillium biosurface, which enhance its biocompatibility and functionality. The device is disposable, ensuring sterility and reducing the risk of cross-contamination between procedures.
Clinical Applications
This device is commonly used in interventional oncology settings for the ablation of tumors. It is particularly useful in minimally invasive procedures where precise targeting of tumor tissue is required. The bio-probe is typically employed in hospital settings, often in the interventional radiology suite, and is used for patients with tumors that are difficult to access or treat through traditional surgical methods.
Indications for Use
The FDA-cleared indications for this device include its use in the ablation of tumors. It is intended for patients with specific types of tumors that are amenable to ablation therapy, providing a minimally invasive treatment option.
Practical Considerations
The bio-probe disposable insert is available in various sizes to accommodate different procedural needs. It is compatible with standard ablation equipment, and clinicians should be familiar with the specific technique required for its use to ensure optimal outcomes. Proper training in its application is recommended.
Frequently Asked Questions
What is bio-probe disposable insert used for?
It is used for the ablation of tumors, providing a minimally invasive treatment option for certain types of tumors.
What specialties typically use this device?
Oncologists and interventional radiologists typically use this device in tumor ablation procedures.
What are the FDA-cleared indications?
The device is cleared for use in the ablation of tumors, offering a treatment option for patients with specific types of tumors.
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.