Clearance Summary
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 received FDA 510(k) clearance under submission number K260309, sponsored by Ambu A/S. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2026-09-16.
- Submission: K260309
- Applicant / Sponsor: Ambu A/S
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.4680
- Decision date: 2026-09-16
Classification & Regulation
This clearance is catalogued under FDA product code EOQ and 21 CFR 874.4680, within the Ear, Nose, Throat review panel as a Class II device.