510(k) K223183

Light-Guide Cables by Olympus Winter & Ibe GmbH — Product Code HBI

K223183 is an FDA 510(k) premarket notification submitted by Olympus Winter & Ibe GmbH for the device "Light-Guide Cables". The FDA issued a decision of Substantially Equivalent on January 13, 2023. The device falls under product code HBI (Illuminator, Fiberoptic, Surgical Field), a Class II device regulated under 21 CFR 878.4580. Olympus Winter & Ibe GmbH has at least 10 other 510(k) clearances on record.