About This 510(k) Submission
K243075 is an FDA 510(k) clearance for the Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280), a Endoscope Channel Accessory (Class II — Special Controls, product code ODC), submitted by STERIS Corporation (Minneapolis, US). The FDA issued a Cleared decision on November 8, 2024, 42 days after receiving the submission on September 27, 2024. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.