510(k) K002235

HORIZONS ERCP CANNULA by Horizons Intl. Corp. — Product Code FGE

K002235 is an FDA 510(k) premarket notification submitted by Horizons Intl. Corp. for the device "HORIZONS ERCP CANNULA". The FDA issued a decision of Substantially Equivalent on January 23, 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. Horizons Intl. Corp. has at least 9 other 510(k) clearances on record.