Endoflux™ Biliary & Pancreatic Stent Sets

The Endoflux™ Biliary & Pancreatic Stent Sets are endoscopic devices used to drain obstructed biliary and pancreatic ducts. The product line includes stents in various sizes (5-11.5 Fr, 2-18 cm lengths), along with guiding catheters, pushers, and stent introducer sets for placement via endoscopy over a guide wire.

The devices feature polymeric stents with radiopaque material, bent shapes and anti-migration features such as pigtails and flaps. Side ports assist drainage. Stents are deployed endoscopically over a guide wire. The introducer components include radiopaque bands and are supplied sterile, sterilized by ethylene oxide. Materials, dimensions, stent designs, and loading aids vary compared to predicates.

ISO 10993-1:2018 (Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process) and ISO 10993-1 (September 8, 2023) were used for biocompatibility evaluation. Performance testing included dimensional, visual, tensile strength, MRI conditional, radiosity, flow rate, and shelf-life testing per Medi-Globe's design control system.

The subject device has the same indications for use and technological characteristics as the predicate devices (Cook Biliary/Pancreatic Stents cleared under K172044 and K172057). Non-clinical testing demonstrates that the device meets design input requirements and establishes no change in safety and effectiveness profile compared to predicates, supporting substantial equivalence.