510(k) K984255

OLYMPUS HX-20 SERIES LIGATING DEVICE by Olympus Corp of America — Product Code MND

K984255 is an FDA 510(k) premarket notification submitted by Olympus Corp of America for the device "OLYMPUS HX-20 SERIES LIGATING DEVICE". The FDA issued a decision of Substantially Equivalent on January 12, 1999. The device falls under product code MND (Ligator, Esophageal), a Class II device regulated under 21 CFR 876.4400. Olympus Corp of America has at least 1 other 510(k) clearance on record.