FDA cleared the Ambu® aScope Gastro; Ambu® aScope Gastro Large from Ambu A/S on Sep 16, 2026 under K261400, a traditional 510(k). The device falls under product code FDS, Gastroscope And Accessories, Flexible/Rigid, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.
FDA logged the submission as received on Apr 29, 2026. The decision came 140 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.
Ambu A/S has 3 other decisions in the tracker over the last 12 months: K260309 (Ambu® aScope 5 Broncho 2.7/1.2; Ambu® aScope 5 Broncho 4.2/2.2; Ambu® aScope 5 Broncho 4.2/2.2 Sampler Set), K260578 (Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (Models 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (Models 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US)), K251583 (Ambu® Virobac II® Exhalation Filter).