510(k) K030053

JOSTENT SELFX, MODELS 015SX4406; 015SX4408; 015SX4410; 015SX680; 015SX6808; 015SX6810 by Jomed AG — Product Code FGE

K030053 is an FDA 510(k) premarket notification submitted by Jomed AG for the device "JOSTENT SELFX, MODELS 015SX4406; 015SX4408; 015SX4410; 015SX680; 015SX6808; 015SX6810". The FDA issued a decision of Substantially Equivalent on March 31, 2003. 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. Jomed AG has at least 8 other 510(k) clearances on record.