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
217–240 of 450
Cleared Oct 17, 1979
INSTRUMENT PAD
K791864
Procter & Gamble Mfg. Co.
General Hospital · 26d
Cleared Oct 04, 1979
BARRIER & FACE MASK WITH INNER FACING
K791719
Surgikos, Inc.
General Hospital · 35d
Cleared Aug 28, 1979
BARRIER* C-ARM DRAPE
K791438
Surgikos, Inc.
General Hospital · 28d
Cleared Aug 28, 1979
BARRIER* OVERHEAD TABLE DRAPE
K791439
Surgikos, Inc.
General Hospital · 28d
Cleared Aug 28, 1979
BARRIER* X-RAY CASSETTE DRAPE
K791440
Surgikos, Inc.
General Hospital · 28d
Cleared Aug 28, 1979
FABRIC 450* TOWEL DRAPE
K791486
Surgikos, Inc.
General Hospital · 22d
Cleared Aug 28, 1979
BARRIER *450* TAPE STRIP
K791500
Surgikos, Inc.
General Hospital · 26d
Cleared Jul 03, 1979
SURGICAL FACE MASK
K790970
Carapace, Inc.
General Hospital · 42d
Cleared Jun 20, 1979
ACCU-SORB STERILE STOCKINETTES
K791070
Medline Industries, Inc.
General Hospital · 8d
Cleared Jun 15, 1979
CARDIAC CATHETERIZATION SHEETS/PACKS
K791032
Surgikos, Inc.
General Hospital · 11d
Cleared Jun 05, 1979
KIMLON IMPERVIOUS STOCKINETTES
K790972
Kimberly-Clark Corp.
General Hospital · 14d
Cleared May 11, 1979
BARRIER SURGICAL DRAPES W/ DRISITE* W/MICROCIDE*
K790725
Surgikos, Inc.
General Hospital · 28d
Cleared May 08, 1979
KIMLON UNIVERSAL DRAPE
K790636
Kimberly-Clark Corp.
General Hospital · 36d
Cleared May 04, 1979
TREATED BARRIER INCISE DRAPE
K790431
Surgikos, Inc.
General Hospital · 63d
Cleared Apr 10, 1979
IMPERVIOUS STERILE STOCKINETTE
K790634
Anago, Inc.
General Hospital · 7d
Cleared Apr 04, 1979
DELTA-NET
K790341
Johnson & Johnson Professionals, Inc.
General Hospital · 42d
Cleared Feb 21, 1979
LIMB SHEET WITH FABRIC 450
K790225
Surgikos, Inc.
General Hospital · 19d
Cleared Feb 16, 1979
PADIATRY PACK & SHEET WITH FABRIC 450
K790224
Surgikos, Inc.
General Hospital · 14d
Cleared Jan 10, 1979
STOCKINETTE, DISPOSABLESURGICAL
K782091
Anago, Inc.
General Hospital · 27d
Cleared Dec 29, 1978
STOCKINETTE
K781944
Kimberly-Clark Corp.
General Hospital · 38d
Cleared Aug 31, 1978
U-DRAPE, BOUNDARY
K781172
Procter & Gamble Mfg. Co.
General Hospital · 49d
Cleared Aug 21, 1978
MAGNETIC DRAPE - INSTRUMENT HOLDER
K780865
Devon Industries, Inc.
General Hospital · 83d
Cleared Aug 14, 1978
ASPIRATION NEEDLE
K780784
Ferris Mfg. Corp.
General Hospital · 94d
Cleared Aug 14, 1978
BARRIER PEDIATRIC/INCISE DRAPE 450
K780839
Surgikos, Inc.
General Hospital · 83d