510(k) K203492

Instrument tray, for semi-rigid ureteroscope by Olympus Winter & Ibe GmbH — Product Code KCT

K203492 is an FDA 510(k) premarket notification submitted by Olympus Winter & Ibe GmbH for the device "Instrument tray, for semi-rigid ureteroscope". The FDA issued a decision of Substantially Equivalent on September 15, 2021. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Olympus Winter & Ibe GmbH has at least 10 other 510(k) clearances on record.