FXY — Hood, Surgical Class II
FDA product code FXY covers "Hood, Surgical", a Class II medical device regulated under 21 CFR 878.4040. Submissions are reviewed by the General, Plastic Surgery panel. At least 13 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FXY
- Device Class
- Class II
- Regulation Number
- 878.4040
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K222214 | thi total healthcare innovation | ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood) | October 17, 2023 |
| K200493 | stryker corporation | Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgi | March 21, 2020 |
| K140588 | stryker corporation | FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENS | June 26, 2014 |
| K904969 | chicago assoc. for retarded citizens | HOOD, OPERATING, SURGICAL | December 12, 1990 |
| K904276 | anago | DISPOSABLE BEARD COVER | November 21, 1990 |
| K903533 | biomedical devices | STERI-SHIELD | October 19, 1990 |
| K902677 | biomedical devices | STERI-SHIELD | August 17, 1990 |
| K880431 | james river | CARETEX SURGEON'S HOODS | February 24, 1988 |
| K770261 | sherwood medical industries | HOOD, CLARION SURGEONS | March 1, 1977 |
| K770257 | sherwood medical industries | HOOD & BEARD COVER, CLARION SURGEON'S | February 25, 1977 |
| K761070 | owenby | P.S.M. SURGICAL HOOD | December 30, 1976 |
| K760855 | surgikos | BARRIER SURGICAL HOOD | November 3, 1976 |
| K760865 | surgikos | BARRIER FASHION BONNET | November 3, 1976 |