510(k) K972582

URESIL GUIDEWIRE by Uresil Corp. — Product Code FGE

K972582 is an FDA 510(k) premarket notification submitted by Uresil Corp. for the device "URESIL GUIDEWIRE". The FDA issued a decision of Substantially Equivalent on November 21, 1997. 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. Uresil Corp. has at least 10 other 510(k) clearances on record.