510(k) K964661

HX-20/21-1 ENDOSCOPIC LIGATOR by Olympus America, Inc. — Product Code MND

K964661 is an FDA 510(k) premarket notification submitted by Olympus America, Inc. for the device "HX-20/21-1 ENDOSCOPIC LIGATOR". The FDA issued a decision of Substantially Equivalent on October 30, 1997. The device falls under product code MND (Ligator, Esophageal), a Class II device regulated under 21 CFR 876.4400. Olympus America, Inc. has at least 10 other 510(k) clearances on record.