510(k) K171692

Instrument basket, for EndoEYE by Olympus Winter & Ibe GmbH — Product Code KCT

K171692 is an FDA 510(k) premarket notification submitted by Olympus Winter & Ibe GmbH for the device "Instrument basket, for EndoEYE". The FDA issued a decision of Substantially Equivalent on April 2, 2018. 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.