Clearance Summary
T-Edge 10, T-Edge 11 received FDA 510(k) clearance under submission number K213080, sponsored by Tuttnauer , Ltd.. 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 2022-01-04.
- Submission: K213080
- Applicant / Sponsor: Tuttnauer , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6880
- Decision date: 2022-01-04
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.