FDA 510(k) Applications for Medical Device Product Code "FXY"
(Hood, Surgical)
| FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
| K140588 |
STRYKER CORPORATION |
FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENS |
06/26/2014 |
| K200493 |
Stryker Corporation |
Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, Pullover |
03/21/2020 |
| K222214 |
THI Total Healthcare Innovation GmbH |
ViVi« Surgical Helmet System (ViVi« Helmet, ViVi« Helmet HPL, ViVi« Hood) |
10/17/2023 |
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