FXY
- Product code
- FXY
- Device name
- Hood, Surgical
- Device class
- Class 2
- 21 CFR
- 21 CFR 878.4040
- Medical specialty
- General, Plastic Surgery
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 13
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K222214 | 2023-10-17 | Thi Total Healthcare Innovation GmbH | ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® He |
Official FDA classification page: FXY
Classification and pathway per current FDA publications. Data from openFDA (CC0).