Evis Exera II Duodenovideoscope Olympus Tjf Type Q180v

K143153 is the FDA 510(k) clearance record for EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V, a class II device, cleared for Olympus Medical Systems Corp. on 2016-01-15 under FDA product code FDT (Duodenoscope And Accessories, Flexible/Rigid). FDA's definition for product code FDT reads: "To examine the duodenum and to perform various procedures within the duodenum. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82...". FDA records list 186 510(k) clearances for Olympus Medical Systems Corp., from 2004-12-09 to 2026-07-31. As of 2026-09-10, FDA records show 3 recalls naming K143153.