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
97–120 of 450
Cleared Aug 20, 1980
BARRIER APERTURED DRAPE
K801864
Surgikos, Inc.
General Hospital · 15d
Cleared May 20, 1980
WHITE KNIGHT SUPPLEMENTAL DRAPE
K800928
G.D. Searle and Co.
General Hospital · 29d
Cleared May 20, 1980
BOUNDARY EXTREMITY DRAPE
K801132
Procter & Gamble Mfg. Co.
General Hospital · 8d
Cleared Mar 20, 1980
ZEISS DISPOSABLE, STERILE SURGICAL DRAPE
K800552
Carl Zeiss, Inc.
General Hospital · 10d
Cleared Jan 11, 1980
STERILIZATION PROCESS CHANGE BOUNDARY
K792621
Procter & Gamble Mfg. Co.
General Hospital · 23d
Cleared Jan 11, 1980
STERILIZATION PROCESS/ABSORBENT TOWEL
K792623
Procter & Gamble Mfg. Co.
General Hospital · 23d
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 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