510(k) K014166

UHI-3 HIGH FLOW INSUFFLATION UNIT by Olympus Optical Co., Ltd. — Product Code HIF

K014166 is an FDA 510(k) premarket notification submitted by Olympus Optical Co., Ltd. for the device "UHI-3 HIGH FLOW INSUFFLATION UNIT". The FDA issued a decision of Substantially Equivalent on June 25, 2002. The device falls under product code HIF (Insufflator, Laparoscopic), a Class II device regulated under 21 CFR 884.1730. Olympus Optical Co., Ltd. has at least 10 other 510(k) clearances on record.