FDA Product Code
FDA Product Code FXY — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4040
510(k) Clearances — 13 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K222214 | ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood) | Thi Total Healthcare Innovation GmbH | 2023-10-17 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K140588 | FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENS | Stryker Corporation | 2014-06-26 | Special | PDF ↗ |
| K904969 | HOOD, OPERATING, SURGICAL | Chicago Assoc. For Retarded Citizens | 1990-12-12 | Traditional | PDF ↗ |
| K904276 | DISPOSABLE BEARD COVER | Anago, Inc. | 1990-11-21 | Traditional | PDF ↗ |
| K903533 | STERI-SHIELD | Biomedical Devices, Inc. | 1990-10-19 | Traditional | PDF ↗ |
| K902677 | STERI-SHIELD | Biomedical Devices, Inc. | 1990-08-17 | Traditional | PDF ↗ |
| K880431 | CARETEX SURGEON'S HOODS | James River Corp. | 1988-02-24 | Traditional | PDF ↗ |
| K770261 | HOOD, CLARION SURGEONS | Sherwood Medical Industries | 1977-03-01 | Traditional | PDF ↗ |
| K770257 | HOOD & BEARD COVER, CLARION SURGEON'S | Sherwood Medical Industries | 1977-02-25 | Traditional | PDF ↗ |
| K761070 | P.S.M. SURGICAL HOOD | The Owenby Co. | 1976-12-30 | Traditional | PDF ↗ |
| K760855 | BARRIER SURGICAL HOOD | Surgikos, Inc. | 1976-11-03 | Traditional | PDF ↗ |
| K760865 | BARRIER FASHION BONNET | Surgikos, Inc. | 1976-11-03 | Traditional | PDF ↗ |
Product code FXY · Class II · General, Plastic Surgery. Data: openFDA.