510(k) K002650

VAN ANDLE DILATION, EMERALD GUIDEWIRE, MODEL VAD6, 502-726 by Bentec Medical, Inc. — Product Code FGE

K002650 is an FDA 510(k) premarket notification submitted by Bentec Medical, Inc. for the device "VAN ANDLE DILATION, EMERALD GUIDEWIRE, MODEL VAD6, 502-726". The FDA issued a decision of Substantially Equivalent on February 16, 2001. 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. Bentec Medical, Inc. has at least 2 other 510(k) clearances on record.