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barrx sb rfa endoscopic catheter
Covidien
Summary: The Barrx SB RFA Endoscopic Catheter is a medical device used for radiofrequency ablation of certain tumors. It is typically used by gastroenterologists and other specialists in endoscopic procedures.
FDA Clearance Information
Pathway
510K
Number
K173559 ↗
Decision Date
January 18, 2018
Product Code
KNS
Device Class
Class 2
Evidence
0 studies
The Barrx SB RFA Endoscopic Catheter was cleared through the FDA 510(k) pathway on January 18, 2018. Manufactured by Covidien, it is a Class 2 medical device.
What It Is
The Barrx SB RFA Endoscopic Catheter is a specialized device used in endoscopic procedures to deliver radiofrequency energy for the ablation of abnormal tissue. It works by applying controlled heat to targeted areas, effectively destroying unwanted tissue while minimizing damage to surrounding structures. This device is particularly useful in treating conditions that require precise ablation, such as certain types of tumors.
Clinical Applications
This device is commonly used in gastroenterology for the treatment of Barrett's esophagus and other gastrointestinal conditions that may benefit from targeted ablation. It is typically employed in outpatient or hospital endoscopy settings. Patients with precancerous lesions or localized tumors in the GI tract are common candidates for procedures using this device.
Indications for Use
The FDA indications for the Barrx SB RFA Endoscopic Catheter include the ablation of precancerous and cancerous lesions in the gastrointestinal tract. It is designed for patients who require precise tissue removal to manage or prevent tumor growth.
Practical Considerations
The Barrx SB RFA Endoscopic Catheter is compatible with standard endoscopic equipment. Clinicians should be trained in radiofrequency ablation techniques to ensure effective and safe use. Proper sizing and positioning are crucial for optimal results.
Frequently Asked Questions
What is Barrx SB RFA Endoscopic Catheter used for?
It is used for the radiofrequency ablation of abnormal tissue, such as precancerous lesions and certain tumors in the gastrointestinal tract.
What specialties typically use this device?
Gastroenterologists and specialists in endoscopic procedures commonly use this device.
What are the FDA-cleared indications?
The device is indicated for the ablation of precancerous and cancerous lesions in the gastrointestinal tract.
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.