510(k) K251658

Endoflux™ Biliary & Pancreatic Stent Sets by Medi-Globe GmbH — Product Code FGE

K251658 is an FDA 510(k) premarket notification submitted by Medi-Globe GmbH for the device "Endoflux™ Biliary & Pancreatic Stent Sets". The FDA issued a decision of Substantially Equivalent on April 16, 2026. The device falls under product code FGE (Stents, Drains And Dilators For The Biliary Ducts), a Class II device regulated under 21 CFR 876.5010. Medi-Globe GmbH has at least 10 other 510(k) clearances on record.