510(k) K260835

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

K260835 is an FDA 510(k) premarket notification submitted by Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) for the device "ARCHIMEDES Biodegradable Stent (Medium)". The FDA issued a decision of Substantially Equivalent on July 27, 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. Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) has at least 1 other 510(k) clearance on record.