510(k) K243075

Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280) by STERIS Corporation — Product Code ODC

K243075 is an FDA 510(k) premarket notification submitted by STERIS Corporation for the device "Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280)". The FDA issued a decision of Substantially Equivalent on November 8, 2024. The device falls under product code ODC (Endoscope Channel Accessory), a Class II device regulated under 21 CFR 876.1500. STERIS Corporation has at least 10 other 510(k) clearances on record.