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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 ?
510(k)
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.
FDA-Cleared Indications
- Ablation of non-dysplastic or dysplastic Barrett’s esophagus tissue when used with compatible Barrx radiofrequency ablation accessories, according to their labeling.
- Treatment of abnormal esophageal mucosa in patients with Barrett’s esophagus as specified in the applicable device and accessory instructions for use.
Clinical Applications
- Endoscopic radiofrequency ablation of Barrett’s esophagus.
- Ablation of visible or circumferential abnormal esophageal mucosa using compatible balloon or focal ablation catheters.
- Use in an endoscopy suite or hospital setting by trained gastroenterology clinicians.
Practical Considerations
- The generator is used with compatible Barrx RFA catheters and an endoscope; the generator alone does not contact tissue.
- The treatment requires endoscopic visualization, correct catheter positioning, and adherence to the labeled energy settings and procedural technique.
- It is intended for gastrointestinal endoscopic use and should not be assumed to be suitable for vascular, cardiac, neurointerventional, or other applications.
- MRI safety depends on the specific generator, connected accessories, and implanted or retained materials; the device should not be taken into an MRI environment unless the current manufacturer labeling confirms compatibility.
- Contraindications, precautions, catheter sizes, and treatment parameters are accessory-specific and should be checked in the current instructions for use.
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.