Clearance Summary
ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood) received FDA 510(k) clearance under submission number K222214, sponsored by Thi Total Healthcare Innovation GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2023-10-17.
- Submission: K222214
- Applicant / Sponsor: Thi Total Healthcare Innovation GmbH
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 2023-10-17
Classification & Regulation
This clearance is catalogued under FDA product code FXY and 21 CFR 878.4040, within the General, Plastic Surgery review panel as a Class II device.