ERCP catheter, non-balloon, electrosurgical

An ERCP catheter, non-balloon, electrosurgical is a flexible tube used during endoscopic retrograde cholangiopancreatography (ERCP) to deliver contrast fluid for imaging and to apply monopolar electrosurgical energy for cutting tissue at the major duodenal papilla. It is designed to be passed through an endoscope and used to perform sphincterotomy or papillotomy without the use of an inflatable balloon.

This category of device is supplied as a single-use, sterile product intended for one-time clinical use. It does not contain drugs or biologics and is regulated based on its function as an accessory to endoscopic procedures, with regulatory status determined by jurisdiction-specific rules for endotherapy devices.