510(k) K083049

TORNADO ROTATABEL SNARE AND POLYP CATCHER by Horizons Intl. Corp. — Product Code FDI

K083049 is an FDA 510(k) premarket notification submitted by Horizons Intl. Corp. for the device "TORNADO ROTATABEL SNARE AND POLYP CATCHER". The FDA issued a decision of Substantially Equivalent on December 23, 2008. The device falls under product code FDI (Snare, Flexible), a Class II device regulated under 21 CFR 876.4300. Horizons Intl. Corp. has at least 9 other 510(k) clearances on record.