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
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
Cleared
Jun 26, 2014
FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENS
Stryker Corporation
General Hospital
111d
Cleared
Dec 12, 1990
HOOD, OPERATING, SURGICAL
Chicago Assoc. For Retarded Citizens
General Hospital
37d
Cleared
Nov 21, 1990
DISPOSABLE BEARD COVER
Anago, Inc.
General Hospital
63d
Cleared
Oct 19, 1990
STERI-SHIELD
Biomedical Devices, Inc.
General Hospital
74d
Cleared
Aug 17, 1990
STERI-SHIELD
Biomedical Devices, Inc.
General Hospital
60d
Cleared
Feb 24, 1988
CARETEX SURGEON'S HOODS
James River Corp.
General Hospital
23d
Cleared
Mar 01, 1977
HOOD, CLARION SURGEONS
Sherwood Medical Industries
General Hospital
18d
Cleared
Feb 25, 1977
HOOD & BEARD COVER, CLARION SURGEON'S
Sherwood Medical Industries
General Hospital
14d
Cleared
Dec 30, 1976
P.S.M. SURGICAL HOOD
The Owenby Co.
General Hospital
44d
Cleared
Nov 03, 1976
BARRIER SURGICAL HOOD
Surgikos, Inc.
General Hospital
19d
Cleared
Nov 03, 1976
BARRIER FASHION BONNET
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.