Clearance Summary
ORiGO System received FDA 510(k) clearance under submission number K213697, sponsored by Bien-Air Surgery SA. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2022-10-31.
- Submission: K213697
- Applicant / Sponsor: Bien-Air Surgery SA
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4360
- Decision date: 2022-10-31
Classification & Regulation
This clearance is catalogued under FDA product code HBC and 21 CFR 882.4360, within the Neurology review panel as a Class II device.