510(k) K910219

LAPAROMED CHOLANGIOGRAM DEVICE by Laparomed Corp. — Product Code FGE

K910219 is an FDA 510(k) premarket notification submitted by Laparomed Corp. for the device "LAPAROMED CHOLANGIOGRAM DEVICE". The FDA issued a decision of Substantially Equivalent on April 8, 1991. 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. Laparomed Corp. has at least 9 other 510(k) clearances on record.