510(k) K061684

MEDI-GLOBE ROTA-CUT SPHINCTEROTOME by Medi-Globe Corporation — Product Code KNS

K061684 is an FDA 510(k) premarket notification submitted by Medi-Globe Corporation for the device "MEDI-GLOBE ROTA-CUT SPHINCTEROTOME". The FDA issued a decision of Substantially Equivalent on June 27, 2006. The device falls under product code KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories)), a Class II device regulated under 21 CFR 876.4300. Medi-Globe Corporation has at least 6 other 510(k) clearances on record.