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physician industries radiofrequency ablation needle
Physician Industries
Summary: The Physician Industries radiofrequency ablation needle is a medical device used for the ablation of tumors. It is primarily used by interventional radiologists and oncologists to treat certain types of tumors through minimally invasive procedures.
FDA Clearance Information
Pathway 510K
Number K040565 ↗
Decision Date July 22, 2004
Product Code GXD
Device Class Class 2
Evidence 0 studies
The radiofrequency ablation needle by Physician Industries was cleared through the FDA 510(k) pathway on July 22, 2004. It is classified as a Class 2 device under product code GXD.
What It Is
This device is a specialized needle used in radiofrequency ablation procedures to destroy tumor tissue. It works by delivering radiofrequency energy to the target tissue, generating heat that causes cellular destruction. Clinicians use this device to target and treat tumors in a minimally invasive manner, often guided by imaging techniques such as ultrasound or CT.
Clinical Applications
The radiofrequency ablation needle is commonly used in interventional radiology and oncology settings to treat liver, kidney, and lung tumors. It is particularly useful in patients who are not candidates for surgical resection due to the location of the tumor or underlying health conditions. This device is typically used in outpatient or hospital settings, allowing for precise targeting of tumor tissue with minimal impact on surrounding healthy tissue.
Indications for Use
The FDA indications for this device include the treatment of certain types of tumors through ablation. It is intended for patients with tumors that are accessible via a percutaneous approach and where surgical options are limited or not feasible.
Practical Considerations
The needle comes in various sizes to accommodate different tumor sizes and locations. It is compatible with standard radiofrequency generators and requires imaging guidance for accurate placement. Clinicians should be trained in the technique to ensure effective and safe use.
Frequently Asked Questions
What is the radiofrequency ablation needle used for?
It is used for the ablation of tumors, particularly in the liver, kidney, and lung, through minimally invasive procedures.
What specialties typically use this device?
Interventional radiologists and oncologists typically use this device in clinical settings.
What are the FDA-cleared indications?
The device is indicated for the treatment of certain tumors that are accessible via a percutaneous approach, especially when surgical options are limited.
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.