(70 days)
The FlexStent® Biliary Self Expanding Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
Not Found
This document is a 510(k) clearance letter for the FlexStent® Biliary Self Expanding Stent System, indicating it has been found substantially equivalent to a predicate device. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria, which would typically be found in a detailed study report or a summary of safety and effectiveness.
Therefore, I cannot provide the requested information from the provided text. The document is primarily an FDA communication approving the device for marketing with specific labeling limitations.
§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.