510(k) K243412

ARCHIMEDES Biodegradable Pancreatic Stent by Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) — Product Code FGE

K243412 is an FDA 510(k) premarket notification submitted by Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) for the device "ARCHIMEDES Biodegradable Pancreatic Stent". The FDA issued a decision of Substantially Equivalent on July 16, 2025. 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.