Omegascope

K924228 is the FDA 510(k) clearance record for OMEGASCOPE, a class II device, cleared for Omega Universal Technologies, Ltd. on 1993-02-26 under FDA product code FBN (Choledochoscope And Accessories, Flexible/Rigid). FDA's definition for product code FBN reads: "to examine and perform procedures within the bile ducts. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807...". FDA records list 3 510(k) clearances for Omega Universal Technologies, Ltd., from 1991-07-31 to 1993-02-26. As of 2026-09-10, FDA records show no recalls naming K924228.