510(k) K022445

VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V by Olympus Optical Co., Ltd. — Product Code HIH

K022445 is an FDA 510(k) premarket notification submitted by Olympus Optical Co., Ltd. for the device "VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V". The FDA issued a decision of Substantially Equivalent on January 24, 2003. The device falls under product code HIH (Hysteroscope (And Accessories)), a Class II device regulated under 21 CFR 884.1690. Olympus Optical Co., Ltd. has at least 10 other 510(k) clearances on record.