Device Dossier

Electrode, electrosurgical, active, hand-controlled, single use

Device Dossier for Electrode, electrosurgical, active, hand-controlled, single use (Electrode, electrosurgical, active, hand-controlled, single use,…

Intended purpose

The Channel RFA Endoscopic Catheter is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract, including, but not limited to, Barrett's esophagus and esophageal squamous cell neoplasia, defined as moderate grade intraepithelial neoplasia, high-grade intraepithelial neoplasia, and/or early; squamous cell carcinoma of the esophagus limited to the lamina propria.

TGA Public Summary