Clearance Summary
Ambu® aScope 5 Broncho 4.2/2.2 Sampler Set received FDA 510(k) clearance under submission number K232582, sponsored by Ambu A/S. The device was reviewed via the Special premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2023-09-20.
- Submission: K232582
- Applicant / Sponsor: Ambu A/S
- Clearance pathway: Special
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.4680
- Decision date: 2023-09-20
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.