510(k) K943629

GIP/MEDI-GLOBE PAPILLOTOME by Medi-Globe Corp. — Product Code KNS

K943629 is an FDA 510(k) premarket notification submitted by Medi-Globe Corp. for the device "GIP/MEDI-GLOBE PAPILLOTOME". The FDA issued a decision of Substantially Equivalent on May 26, 1995. 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 Corp. has at least 10 other 510(k) clearances on record.