ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)
FDA 510(k) K222214 · Thi Total Healthcare Innovation GmbH
510(k) numberK222214
Submission
- Device name
- ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)
- Applicant
- Thi Total Healthcare Innovation GmbH
Feistritz Im Rosental, AT - Received
- July 25, 2022
- Decision date
- October 17, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FXY – Hood, Surgical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4040
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code FXY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K200493 | Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical…FXY · Traditional | Stryker Corporation | 03/21/2020SE |
| K140588 | Flyte Hybrid Hood, Flyte Hybrid Hood with Peelaway LensFXY · Special | Stryker Corporation | 06/26/2014SE |
| K904969 | Hood, Operating, SurgicalFXY · Traditional | Chicago Assoc. For Retarded Citizens | 12/12/1990SE |
| K904276 | Disposable Beard CoverFXY · Traditional | Anago, Inc. | 11/21/1990SE |
| K903533 | Steri-ShieldFXY · Traditional | Biomedical Devices, Inc. | 10/19/1990SE |
| K902677 | Steri-ShieldFXY · Traditional | Biomedical Devices, Inc. | 08/17/1990SE |
| K880431 | Caretex Surgeon's HoodsFXY · Traditional | James River Corp. | 02/24/1988SE |
| K770261 | Hood, Clarion SurgeonsFXY · Traditional | Sherwood Medical Industries | 03/01/1977SE |
| K770257 | Hood & Beard Cover, Clarion Surgeon'sFXY · Traditional | Sherwood Medical Industries | 02/25/1977SE |
| K761070 | P.S.M. Surgical HoodFXY · Traditional | The Owenby Co. | 12/30/1976SE |
More from The Owenby Co.
| 510(k) | Device | Decision |
|---|---|---|
| K243522 | ViVi® Toga PremiumFYA · Traditional | 05/30/2025SE |
Questions and answers
When was ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood) cleared by the FDA?
ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood) (K222214) received a 510(k) decision of Substantially Equivalent on October 17, 2023, 449 days after the submission was received.
What is the product code of K222214?
The FDA product code is FXY – Hood, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.4040.