510(k) K910768

SURGITEK(R) 420 CM G.I. INFUSION GUIDEWIRE by Surgitek Medical Engineering Corp. — Product Code FGE

K910768 is an FDA 510(k) premarket notification submitted by Surgitek Medical Engineering Corp. for the device "SURGITEK(R) 420 CM G.I. INFUSION GUIDEWIRE". The FDA issued a decision of Substantially Equivalent on March 19, 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. Surgitek Medical Engineering Corp. has at least 10 other 510(k) clearances on record.