Clearance Summary
Ambu® aScope Gastro; Ambu® aScope Gastro Large received FDA 510(k) clearance under submission number K261400, sponsored by Ambu A/S. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2026-09-16.
- Submission: K261400
- Applicant / Sponsor: Ambu A/S
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2026-09-16
Classification & Regulation
This clearance is catalogued under FDA product code FDS and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.