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rfa-1717dig rfa-1717dic
Astel
Summary: The rfa-1717dig and rfa-1717dic are tumor ablation devices used primarily by oncologists and interventional radiologists for treating tumors. They offer a minimally invasive option for tumor management.
FDA Clearance Information
Pathway
510K
Number
K212051 ↗
Decision Date
August 25, 2021
Product Code
MQB
Device Class
Class 2
Evidence
0 studies
The rfa-1717dig and rfa-1717dic, manufactured by Astel, received FDA 510k clearance on August 25, 2021. These devices are classified as Class 2 under product code MQB.
What It Is
The rfa-1717dig and rfa-1717dic are radiofrequency ablation devices designed for the treatment of tumors. They work by delivering high-frequency electrical currents to generate heat, which destroys cancerous tissue. This minimally invasive approach allows for precise targeting of tumors while sparing surrounding healthy tissue.
Clinical Applications
These devices are commonly used in oncology and interventional radiology settings for the treatment of liver, kidney, and lung tumors. They are particularly useful in patients who are not surgical candidates or when tumors are located in difficult-to-reach areas. The procedure is typically performed in a hospital or outpatient setting, often under imaging guidance.
Indications for Use
The FDA-cleared indications for these devices include the ablation of soft tissue tumors. They are suitable for patients with primary or metastatic tumors who require a minimally invasive treatment option.
Practical Considerations
The rfa-1717dig and rfa-1717dic devices come in various sizes to accommodate different tumor sizes and locations. They are compatible with standard imaging modalities for guidance, and clinicians should be trained in the specific technique to ensure optimal outcomes.
Frequently Asked Questions
What is rfa-1717dig/rfa-1717dic used for?
These devices are used for the ablation of tumors, providing a minimally invasive treatment option for cancer patients.
What specialties typically use this device?
Oncologists and interventional radiologists primarily use these devices in clinical practice.
What are the FDA-cleared indications?
The devices are indicated for the ablation of soft tissue tumors, suitable for patients needing minimally invasive treatment.
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.