Clearance Summary
Enbio S received FDA 510(k) clearance under submission number K210279, sponsored by Enbio Group AG. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2021-10-29.
- Submission: K210279
- Applicant / Sponsor: Enbio Group AG
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6880
- Decision date: 2021-10-29
Classification & Regulation
This clearance is catalogued under FDA product code FLE and 21 CFR 880.6880, within the General Hospital review panel as a Class II device.