FXY · Class II · 21 CFR 878.4040

FDA Product Code FXY: Hood, Surgical

Leading manufacturers include Stryker Corporation, Surgikos, Inc. and Sherwood Medical Industries.

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
1–13 of 13
Cleared Oct 17, 2023
ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)
K222214
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
K200493
Stryker Corporation
General Hospital · 22d
Cleared Jun 26, 2014
FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENS
K140588
Stryker Corporation
General Hospital · 111d
Cleared Nov 21, 1990
DISPOSABLE BEARD COVER
K904276
Anago, Inc.
General Hospital · 63d
Cleared Mar 01, 1977
HOOD, CLARION SURGEONS
K770261
Sherwood Medical Industries
General Hospital · 18d
Cleared Feb 25, 1977
HOOD & BEARD COVER, CLARION SURGEON'S
K770257
Sherwood Medical Industries
General Hospital · 14d
Cleared Nov 03, 1976
BARRIER SURGICAL HOOD
K760855
Surgikos, Inc.
General Hospital · 19d
Cleared Nov 03, 1976
BARRIER FASHION BONNET
K760865
Surgikos, Inc.
General Hospital · 16d

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.