510(k) K213207

Sheath, Stopcock Accessory by Olympus Winter & Ibe GmbH — Product Code HIH

K213207 is an FDA 510(k) premarket notification submitted by Olympus Winter & Ibe GmbH for the device "Sheath, Stopcock Accessory". The FDA issued a decision of Substantially Equivalent on December 22, 2021. The device falls under product code HIH (Hysteroscope (And Accessories)), a Class II device regulated under 21 CFR 884.1690. Olympus Winter & Ibe GmbH has at least 10 other 510(k) clearances on record.