FDA cleared the EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F) from Olympus Medical Systems Corporation on Aug 27, 2026 under K260401, a traditional 510(k). The device falls under product code PSV, Ultrasound Bronchoscope, regulated at 21 CFR 892.1550 as a Class 2 device. The review panel was Radiology.
FDA logged the submission as received on Feb 6, 2026. The decision came 202 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.
Olympus Medical Systems Corporation has 8 other decisions in the tracker over the last 12 months: K260824 (Gastrointestinal Videoscope Olympus GIF-2T1500), K260856 (Disposable Distal Attachment D-201-13404), K261183 (EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)), K254056 (THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS)).