FDA Product Code FXY: Hood, Surgical
Leading manufacturers include Stryker Corporation and Thi Total Healthcare Innovation GmbH.
13
Total
13
Cleared
73d
Avg days
1976
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Hood, Surgical Devices (Product Code FXY)
13 devices
Cleared
Oct 17, 2023
ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)
Thi Total Healthcare Innovation GmbH
General Hospital
449d
Cleared
Mar 21, 2020
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
General Hospital
22d
About Product Code FXY - Regulatory Context
510(k) Submission Activity
13 total 510(k) submissions under product code FXY since 1976, with 13 receiving FDA clearance (average review time: 73 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.