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barrx flex rfa energy generator
Covidien
Summary: The Barrx Flex RFA Energy Generator is a medical device used for radiofrequency ablation, primarily by gastroenterologists to treat conditions like Barrett's esophagus. It is designed to deliver controlled energy to ablate diseased tissue.
FDA Clearance Information
Pathway
510K
Number
K160360 ↗
Decision Date
April 5, 2016
Product Code
GEI
Device Class
Class 2
Evidence
0 studies
The Barrx Flex RFA Energy Generator was cleared through the FDA 510k pathway on April 5, 2016. Manufactured by Covidien, it is a Class 2 medical device under product code GEI.
What It Is
The Barrx Flex RFA Energy Generator is a device that delivers radiofrequency energy for the ablation of diseased tissue. It works by generating heat to remove or destroy abnormal cells, particularly in the esophagus. This device is part of a treatment strategy for conditions like Barrett's esophagus, where it helps prevent progression to esophageal cancer.
Clinical Applications
Clinically, the Barrx Flex RFA Energy Generator is used in gastroenterology, particularly for patients with Barrett's esophagus. It is typically used in outpatient or endoscopy suite settings. The device is beneficial for patients with precancerous changes in the esophagus, aiming to reduce the risk of progression to cancer.
Indications for Use
The FDA-cleared indications for this device include the treatment of Barrett's esophagus, a condition where the lining of the esophagus is damaged by stomach acid and can lead to cancer. It is used to ablate or remove the diseased tissue.
Practical Considerations
The Barrx Flex RFA Energy Generator is compatible with various endoscopic devices and requires specific training for safe and effective use. Clinicians should be aware of the sizing and energy settings to ensure optimal outcomes during procedures.
Frequently Asked Questions
What is Barrx Flex RFA Energy Generator used for?
It is used for radiofrequency ablation of diseased tissue in conditions like Barrett's esophagus.
What specialties typically use this device?
Gastroenterologists primarily use this device in endoscopic procedures.
What are the FDA-cleared indications?
The device is indicated for the ablation of Barrett's esophagus to prevent progression to esophageal cancer.
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.