Clearance Summary
ORiGO System received FDA 510(k) clearance under submission number K221184, sponsored by Bien-Air Surgery SA. 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 2022-11-02.
- Submission: K221184
- Applicant / Sponsor: Bien-Air Surgery SA
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.4250
- Decision date: 2022-11-02
Classification & Regulation
This clearance is catalogued under FDA product code ERL and 21 CFR 874.4250, within the Ear, Nose, Throat review panel as a Class II device.