KKX · Class II · 21 CFR 878.4370

FDA Product Code KKX: Drape, Surgical

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

450
Total
450
Cleared
109d
Avg days
1976
Since
450 devices
25–48 of 450
Cleared Dec 09, 2008
BUSSE SURGICAL DRAPE
K082297
Busse Hospital Disposables, Inc.
General Hospital · 119d
Cleared Oct 10, 2007
ARROW INTERNATIONAL, INC., SURGICAL DRAPES
K071491
Arrow Intl., Inc.
General Hospital · 133d
Cleared Aug 01, 2006
TIBURON DRAPE, MODEL 9349N/ OPTIMA DRAPE, MODEL 9446N
K061762
Cardinal Health, Inc.
General Hospital · 40d
Cleared May 31, 2006
MICROTEK MEDICAL WARMING DRAPE
K060200
Microtek Medical, Inc.
General Hospital · 125d
Cleared Mar 16, 2006
EQUIPMENT SLUSH DRAPE
K053495
Advance Medical Designs, Inc.
General Hospital · 91d
Cleared Feb 15, 2006
GORE-TEX NON-STERILE SURGICAL GOWNS
K052833
Medline Industries, Inc.
General Hospital · 132d
Cleared Dec 01, 2005
STERILE EQUIPMENT COVERS
K052395
Volcano Corporation
General Hospital · 92d
Cleared Aug 15, 2005
3L SURGICAL DRAPES
K043015
3l Medical Products Co., Ltd.
General Hospital · 286d
Cleared Jul 14, 2005
BARRIER SURGICAL DRAPES
K051625
Molnlycke Health Care, Inc.
General Hospital · 24d
Cleared Jun 07, 2005
IMC DRAPES
K050538
Intl. Medsurg Connection, Inc.
General Hospital · 97d
Cleared May 17, 2005
MICROTEK EQUIPMENT DRAPES
K050322
Microtek Medical, Inc.
General Hospital · 97d
Cleared May 10, 2005
LASIK EYE DRAPE
K042977
Odyssey Medical, Inc.
General Hospital · 194d
Cleared Apr 27, 2005
HVO, INC., DISPOSABLE NON-STERILE SURGICAL DRAPES
K050508
Haywood Vocational Opportunities
General Hospital · 58d
Cleared Apr 25, 2005
DRAPE, SURGICAL, X-RAY ELEMENT, MODELS NON STERILE 6120-00, STERILE 704-B, NON STERILE 6124-00X, STERILE 704-BX
K042526
Medical Action Industries, Inc.
General Hospital · 220d
Cleared Mar 16, 2005
MEDLINE STERILE DISPOSABLE SURGICAL GOWNS/DRAPES
K032666
Medline Industries, Inc.
General Hospital · 566d
Cleared Mar 11, 2005
UNDER BUTTOCKS DRAPE
K042893
International Medsurg Connection, Inc.
General Hospital · 143d
Cleared Feb 03, 2005
FOOTHILLS SURGICAL DRAPES
K041224
Foothills Industries, Inc.
General Hospital · 269d
Cleared Dec 10, 2004
PROMEDICAL SURGICAL DRAPES
K042131
Promedical Products Co., Ltd.
General Hospital · 123d
Cleared Oct 05, 2004
PROMEDICAL SURGICAL MAYO STAND COVERS, BAND BAGS, TABLE COVERS AND EQUIPMENT COVERS
K042137
Promedical Products Co., Ltd.
General Hospital · 57d
Cleared Aug 26, 2004
SABRESOURCE DRAPE
K041846
Minrad, Inc.
General Hospital · 49d
Cleared Jun 25, 2004
IMALUX OCT PROBE GUIDE
K041077
Imalux Corporation
General Hospital · 60d
Cleared Sep 22, 2003
ALEXIS WOUND RETRACTOR
K031889
Applied Medical Resources Corp.
General Hospital · 96d
Cleared Sep 10, 2003
STERI-DRAPE SURGICAL DRAPES
K031287
3M Company
General Hospital · 140d
Cleared Apr 29, 2003
DEROYAL DRAPES, STERILE, NON-STERILE
K030365
Deroyal Industries, Inc.
General Hospital · 84d