510(k) K221557

Visera Hysterovideoscope Olympus HYF Type V by Olympus Medical Systems Corporation — Product Code HIH

K221557 is an FDA 510(k) premarket notification submitted by Olympus Medical Systems Corporation for the device "Visera Hysterovideoscope Olympus HYF Type V". The FDA issued a decision of Substantially Equivalent on September 2, 2022. The device falls under product code HIH (Hysteroscope (And Accessories)), a Class II device regulated under 21 CFR 884.1690. Olympus Medical Systems Corporation has at least 10 other 510(k) clearances on record.