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barrx flex rfa energy generator
Covidien Iic
Summary: The Barrx Flex RFA Energy Generator is a medical device used for radiofrequency ablation, primarily in the treatment of Barrett's esophagus. It is typically used by gastroenterologists and surgical specialists in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K141357 ↗
Decision Date
August 21, 2014
Product Code
GEI
Device Class
Class 2
Evidence
0 studies
The Barrx Flex RFA Energy Generator was cleared through the FDA 510(k) pathway on August 21, 2014. Manufactured by Covidien Iic, it is classified as 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 to ablate diseased tissue. It is specifically designed for use in the gastrointestinal tract, particularly for treating Barrett's esophagus, a condition where the esophageal lining changes due to acid reflux. The device works by applying controlled thermal energy to remove the abnormal tissue, allowing healthy tissue to regenerate.
Clinical Applications
This device is commonly used in gastroenterology for the treatment of Barrett's esophagus, a precursor to esophageal cancer. It is typically employed in outpatient endoscopy suites or hospital settings. Patients with chronic gastroesophageal reflux disease (GERD) who have developed Barrett's esophagus are the primary candidates for this treatment.
Indications for Use
The FDA indications for the Barrx Flex RFA Energy Generator include the ablation of precancerous tissue in Barrett's esophagus. It is intended for patients who have been diagnosed with this condition and are at risk of progression to esophageal cancer.
Practical Considerations
The device is compatible with standard endoscopic equipment and requires careful calibration to ensure effective ablation. Clinicians should be trained in the specific technique of radiofrequency ablation to optimize outcomes and minimize complications.
Frequently Asked Questions
What is Barrx Flex RFA Energy Generator used for?
It is used for the ablation of Barrett's esophagus, a condition that can lead to esophageal cancer.
What specialties typically use this device?
Gastroenterologists and surgical specialists typically use this device in endoscopic procedures.
What are the FDA-cleared indications?
The device is indicated for the ablation of precancerous tissue in patients with Barrett's esophagus.
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.