title: Medical Devices; Gastroenterology-Urology Devices; Classification   of the Metallic Biliary Stent System for Benign Strictures. Final order.
abstract: The Food and Drug Administration (FDA) is classifying the metallic biliary stent system for benign strictures into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the metallic biliary stent system for benign strictures' classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
mesh_terms: D001649:Bile Duct Diseases / Q000628:therapy; D003251:Constriction, Pathologic / Q000628:therapy; D018795:Device Approval / Q000331:legislation & jurisprudence*; D004869:Equipment Safety / Q000145:classification; D005762:Gastroenterology / Q000145:classification / Q000295:instrumentation; D006801:Humans; D008670:Metals; D015607:Stents / Q000145:classification*; D014481:United States
chemical_list: D008670:Metals