K222214 is an FDA 510(k) clearance for the ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood). This device is classified as a Hood, Surgical (Class II - Special Controls, product code FXY).
Submitted by Thi Total Healthcare Innovation GmbH (Feistritz Im Rosental, AT). The FDA issued a Cleared decision on October 17, 2023, 449 days after receiving the submission on July 25, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K222214 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 25, 2022 |
| Decision Date | October 17, 2023 |
| Days to Decision | 449 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FXY - Hood, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |