Product code FXY
- Device name
- Hood, Surgical
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.4040
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K222214 | ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood) | Thi Total Healthcare Innovation GmbH | 2023-10-17 |
| K200493 | Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, Pullover | Stryker Corporation | 2020-03-21 |
| K140588 | FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENS | Stryker Corporation | 2014-06-26 |
| K904969 | HOOD, OPERATING, SURGICAL | Chicago Assoc. For Retarded Citizens | 1990-12-12 |
| K904276 | DISPOSABLE BEARD COVER | Anago, Inc. | 1990-11-21 |
| K903533 | STERI-SHIELD | Biomedical Devices, Inc. | 1990-10-19 |
| K902677 | STERI-SHIELD | Biomedical Devices, Inc. | 1990-08-17 |
| K880431 | CARETEX SURGEON'S HOODS | James River Corp. | 1988-02-24 |
| K770261 | HOOD, CLARION SURGEONS | Sherwood Medical Industries | 1977-03-01 |
| K770257 | HOOD & BEARD COVER, CLARION SURGEON'S | Sherwood Medical Industries | 1977-02-25 |
| K761070 | P.S.M. SURGICAL HOOD | The Owenby Co. | 1976-12-30 |
| K760855 | BARRIER SURGICAL HOOD | Surgikos, Inc. | 1976-11-03 |
| K760865 | BARRIER FASHION BONNET | Surgikos, Inc. | 1976-11-03 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 09009607815001 | ViVi PEEL-OFF HOOD | THI Total Healthcare Innovation GmbH | 2025-06-10 |
| 19009607815008 | ViVi PEEL-OFF HOOD | THI Total Healthcare Innovation GmbH | 2025-06-10 |
| 07613327625172 | Steri-Shield | STRYKER CORPORATION | 2025-02-21 |
| 07613327625189 | Steri-Shield | STRYKER CORPORATION | 2025-02-21 |
| 07613327625233 | Steri-Shield | STRYKER CORPORATION | 2025-02-21 |
| 37613327625234 | Steri-Shield | STRYKER CORPORATION | 2025-02-21 |
| 37613327625173 | Steri-Shield | STRYKER CORPORATION | 2025-02-21 |
| 37613327625180 | Steri-Shield | STRYKER CORPORATION | 2025-02-21 |
| 09009607812000 | ViVi Hood | THI Total Healthcare Innovation GmbH | 2023-11-10 |
| 09009607801301 | ViVi Helmet HPL | THI Total Healthcare Innovation GmbH | 2023-11-10 |
| 09009607801004 | ViVi Helmet | THI Total Healthcare Innovation GmbH | 2023-11-10 |
| 37613327466684 | T7 | STRYKER CORPORATION | 2020-05-11 |
| 37613327465892 | T7Plus | STRYKER CORPORATION | 2020-05-11 |
| 37613327465885 | T7Plus | STRYKER CORPORATION | 2020-05-11 |
| 37613327465861 | T7 | STRYKER CORPORATION | 2020-05-11 |
| 07613327466706 | T7Plus | STRYKER CORPORATION | 2020-05-11 |
| 07613327466683 | T7 | STRYKER CORPORATION | 2020-05-11 |
| 07613327465891 | T7Plus | STRYKER CORPORATION | 2020-05-11 |
| 07613327465884 | T7Plus | STRYKER CORPORATION | 2020-05-11 |
| 07613327465860 | T7 | STRYKER CORPORATION | 2020-05-11 |
| 37613327466707 | T7Plus | STRYKER CORPORATION | 2020-05-11 |
| 50192253018774 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2019-06-26 |
| 50192253018781 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2019-06-26 |
| 50885380019812 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2018-12-20 |
| 50630140927162 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2018-12-20 |
| 20885380019811 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2018-12-20 |
| 07613252661078 | Flyte, SurgiCool | STRYKER CORPORATION | 2016-09-23 |
| 37613252661086 | Flyte, SurgiCool | STRYKER CORPORATION | 2016-09-23 |
| 37613252661079 | Flyte, SurgiCool | STRYKER CORPORATION | 2016-09-23 |
| 07613252661085 | Flyte, SurgiCool | STRYKER CORPORATION | 2016-09-23 |