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Autotome™ Pro RX 39
Cannulating Sphincterotome
Details
Device typeERCP catheter, non-balloon, electrosurgical: A flexible, tubular device designed to be inserted into the duodenum via the oral cavity (cannulation) using a flexible endoscope to: 1) infuse contrast media; and 2) deliver electrosurgical current in a monopolar configuration to cut the major duodenal papilla (papillotomy) and approximate tissues, during endoscopic retrograde cholangiopancreatography (ERCP). It includes proximal controls, a distal monopolar electrosurgical cutting wire and an inner lumen(s); it does not incorporate a balloon. This is a single-use device.
FDA categoryUnit, electrosurgical, endoscopic (with or without accessories)
Device ID00191506039233
Catalog numberM00584390
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyLabeling does not contain MRI Safety Information
Size1.3mm Tip diameter
Size3.9F Tip diameter
Size25mm cut wire with insulation