KKX · Class II · 21 CFR 878.4370

FDA Product Code KKX: Drape, Surgical

Leading manufacturers include Surgikos, Inc., Procter & Gamble Mfg. Co. and Deroyal Industries, Inc..

450
Total
450
Cleared
109d
Avg days
1976
Since
450 devices
121–144 of 450
Cleared Aug 13, 1992
DRESSING CHANGE TRAY, STERILE, DISPOSABLE
K921394
Trinity Laboratories, Inc.
General Hospital · 143d
Cleared Aug 04, 1992
QUALTEX TUBE/CORD ORGANIZER
K921350
Deroyal Industries, Inc.
General Hospital · 138d
Cleared Jun 22, 1992
DISPOSABLE O.R. TOWEL, STERILE
K915740
American Threshold Industries, Inc.
General Hospital · 182d
Cleared May 31, 1992
BARRIER DRAPE SHEET WITH SYMETRY FABRIC
K920995
Johnson & Johnson Medical, Inc.
General Hospital · 90d
Cleared May 11, 1992
MINOR LACERATION TRAY W/ INSTRUMENT, STERILE, DISP
K920517
Trinity Laboratories, Inc.
General Hospital · 97d
Cleared Feb 05, 1992
QUALTEX SURGICAL DRAPE, MODIFICATION
K913486
Deroyal Industries, Inc.
General Hospital · 183d
Cleared Jan 09, 1992
ARTHROSCOPY CAMERA DRAPE
K915214
O.R. Concepts, Inc.
General Hospital · 52d
Cleared Dec 02, 1991
QUALTEX MAGNETIC INSTRUMENT DRAPE
K914369
Deroyal Industries, Inc.
General Hospital · 62d
Cleared Oct 11, 1991
CONVERTORS SAFECARE GOWN & DRAPE MATERIAL
K913506
Baxter Healthcare Corp
General Hospital · 65d
Cleared Aug 09, 1991
CUSTOM PROCEDURE TRAY
K911565
Vanguard Medical Concepts, Inc.
General Hospital · 122d
Cleared Jul 25, 1991
DISPOSABLE O.R. TOWEL
K912110
American Threshold Industries, Inc.
General Hospital · 73d
Cleared Jul 23, 1991
PURITAS 100% COTTON ABSORB OPER ROOM SURG TOWELS
K912542
Puritas Health Care, Inc.
General Hospital · 43d
Cleared Feb 19, 1991
QUALTEX SURGICAL DRAPE
K910495
Deroyal Industries, Inc.
General Hospital · 14d
Cleared Jan 02, 1991
CUSTOMED CARDIOVASCULAR PACK
K904693
Customed, Inc.
General Hospital · 78d
Cleared Jan 02, 1991
CUSTOMED ANGIODRAPE PACK FEMORAL
K904694
Customed, Inc.
General Hospital · 78d
Cleared Dec 31, 1990
ORION STERILE OR TOWELS
K903117
Orion Life Systems, Inc.
General Hospital · 168d
Cleared Dec 13, 1990
QUALTEX SURGICAL DRAPE
K904960
Deroyal Industries, Inc.
General Hospital · 38d
Cleared Oct 31, 1990
CUSTOMED CYSTO PACK II
K901705
Customed, Inc.
General Hospital · 202d
Cleared Oct 31, 1990
CUSTOMED LAP PACK II
K902191
Customed, Inc.
General Hospital · 168d
Cleared Sep 19, 1990
CUSTOMED BASIC PACK I
K902884
Customed, Inc.
General Hospital · 79d
Cleared Sep 19, 1990
CUSTOMED BASIC PACK II
K902885
Customed, Inc.
General Hospital · 79d
Cleared Sep 19, 1990
CUSTOMED BASIC PACK III
K902886
Customed, Inc.
General Hospital · 79d
Cleared Jul 12, 1990
CUSTOMED LAP PACK I
K902029
Customed, Inc.
General Hospital · 69d
Cleared Jul 12, 1990
CUSTOMED LAP PACK III
K902030
Customed, Inc.
General Hospital · 69d