Hood, Surgical
FDA product code FXY · Class II (moderate risk) · 21 CFR 878.4040 · General, Plastic Surgery
13510(k) clearances
0PMA approvals
1recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K222214 | ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)FXY · Traditional | Thi Total Healthcare Innovation GmbH | 10/17/2023SE |
| 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 |
| K760865 | Barrier Fashion BonnetFXY · Traditional | Surgikos, Inc. | 11/03/1976SE |
| K760855 | Barrier Surgical HoodFXY · Traditional | Surgikos, Inc. | 11/03/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1461-2024 Class III | HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100)Product was mislabeled as a Surgical Cap at its dispenser level. | O&M Halyard, Inc. | 02/20/2024Open, Classified |