ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)
FDA 510(k) clearance K222214 · decided 2023-10-17
Clearance details
- K-number
- K222214
- Device name
- ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)
- Applicant
- Thi Total Healthcare Innovation GmbH
- Decision
- Substantially Equivalent
- Date received
- 2022-07-25
- Decision date
- 2023-10-17
- Days to decision
- 449 days
- Clearance type
- Traditional
- Product code
- FXY
- Device class
- 2
- Regulation number
- 878.4040
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Feistritz Im Rosental, AT
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, Pullover (K200493) | Stryker Corporation | 2020-03-21 |
| FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENS (K140588) | Stryker Corporation | 2014-06-26 |
| HOOD, OPERATING, SURGICAL (K904969) | Chicago Assoc. For Retarded Citizens | 1990-12-12 |
| DISPOSABLE BEARD COVER (K904276) | Anago, Inc. | 1990-11-21 |
| STERI-SHIELD (K903533) | Biomedical Devices, Inc. | 1990-10-19 |
| STERI-SHIELD (K902677) | Biomedical Devices, Inc. | 1990-08-17 |
| CARETEX SURGEON'S HOODS (K880431) | James River Corp. | 1988-02-24 |
| HOOD, CLARION SURGEONS (K770261) | Sherwood Medical Industries | 1977-03-01 |
| HOOD & BEARD COVER, CLARION SURGEON'S (K770257) | Sherwood Medical Industries | 1977-02-25 |
| P.S.M. SURGICAL HOOD (K761070) | The Owenby Co. | 1976-12-30 |
| BARRIER FASHION BONNET (K760865) | Surgikos, Inc. | 1976-11-03 |
| BARRIER SURGICAL HOOD (K760855) | Surgikos, Inc. | 1976-11-03 |
Recalls involving this device
No recalls on record reference this clearance.