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The Barrx FLEX RFA Energy Generator is indicated for use in the coagulation of soft tissue. The Barrx FLEX RFA Energy Generator is indicated for use in the coagulation of bleeding sites in the gastrointestinal tract including but not limited to the esophagus. Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions and Angiodysplasia.

The subject device, the Barry™ Barrx FLEX RFA Energy Generator is intended to be used with the listed catheters to deliver radiofrequency (RF) energy to the treatment tissue within the gastrointestinal tract through a copper electrode. The catheters include: - HALO360 Ablation Catheter and Sizing Ballon (K093855) - . HALO90 Ablation Catheter (K093008) - HALO60 Ablation Catheter (K112454) ● - HALO® ULTRA Ablation Catheter (K120431) ● - . Barrx Channel RFA Endoscopic Catheter (K130623) The Barrx FLEX RFA Energy Generator is an electrosurgical device that utilizes bipolar RF energy to coagulate biological tissue. The Generator is provided with a footswitch that can initiate inflation of the balloon and initiate or cease delivery of RF energy. The Barrx FLEX RFA Energy Generator is designed to function with a family of single use, disposable Ablation Catheters and Sizing Balloons to deliver the intended therapy.