510(k) K070881

LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660 by Sapimed S.P.A. — Product Code FHN

K070881 is an FDA 510(k) premarket notification submitted by Sapimed S.P.A. for the device "LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660". The FDA issued a decision of Substantially Equivalent on September 26, 2007. The device falls under product code FHN (Ligator, Hemorrhoidal), a Class II device regulated under 21 CFR 876.4400. Sapimed S.P.A. has at least 2 other 510(k) clearances on record.