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 Apr 27, 1995
REMINGTON MEDICAL DISPOSABLE FLUORO/EQUIPMENT COVER MODEL RMI8
K946060
Remington Medical, Inc.
General Hospital · 146d
Cleared Feb 28, 1995
OREX SURGICAL DRAPES
K944859
Thantex Specialties, Inc.
General Hospital · 148d
Cleared Feb 28, 1995
COMPEL SURGICALDRAPES
K944863
Standard Textile Co., Inc.
General Hospital · 148d
Cleared Feb 28, 1995
SPLATTER CONTROL SHIELD
K945486
Taut, Inc.
General Hospital · 112d
Cleared Feb 08, 1995
3M PEDIATRIC LAPAROTOMY SHEET #7938/ #7938NS
K946024
3M Healthcare
General Hospital · 61d
Cleared Feb 02, 1995
CIVCO PROBE BOOT/CORD COVER
K943393
CIVCO Medical Instruments Co., Inc.
General Hospital · 203d
Cleared Feb 02, 1995
3M X-LARGE SHEET #7979/ #7979NS
K946025
3M Healthcare
General Hospital · 55d
Cleared Dec 20, 1994
OREX O.R. TOWEL
K942228
Thantex Specialties, Inc.
General Hospital · 228d
Cleared Nov 07, 1994
CONVERTORS ISO BAC DRAPE MATERIAL
K931267
Baxter Healthcare Corp
General Hospital · 609d
Cleared Sep 07, 1994
SURGICAL DRAPES
K943122
Mallinckrodt Group, Inc.
General Hospital · 70d
Cleared Jul 27, 1994
GLOBAL SHOULDER O.R. DRAPE PACK
K941233
Depuy, Inc.
General Hospital · 134d
Cleared May 26, 1994
MEDSURG STERILE O.R. TOWELS
K940175
Medsurg Industries, Inc.
General Hospital · 135d
Cleared Apr 26, 1994
CONVERTORS OPTI-SORB DRAPE MATERIAL
K940702
Baxter Healthcare Corp
General Hospital · 69d
Cleared Apr 11, 1994
STERILE CONVERTORS SMS POLYPROPYLENE GOWN & DRAPE
K924101
Baxter Healthcare Corp
General Hospital · 606d
Cleared Apr 11, 1994
STSTORZ DP5300 AND DP9502 STERILE DRAPES
K934445
Storz Instrument Co.
General Hospital · 210d
Cleared Feb 09, 1994
CONTAIN-OR
K934215
Dlp, Inc.
General Hospital · 163d
Cleared Feb 03, 1994
ARTHROBOT BI-FOLD DRAPE
K932253
Andronic Devices, Ltd.
General Hospital · 269d
Cleared Mar 03, 1993
VARIOUS UTILITY/SURGICAL DRAPE, STERILE, DISPOSABL
K920346
Trinity Laboratories, Inc.
General Hospital · 401d
Cleared Feb 23, 1993
COMPEL SURGICAL DRAPES
K923811
Standard Textile Co., Inc.
General Hospital · 209d
Cleared Oct 19, 1992
DRAPE UTILITY/SURGICAL STERILE DISPOSABLE
K920284
Trinity Laboratories, Inc.
General Hospital · 271d
Cleared Sep 28, 1992
ULCER WOUND TRAY
K922828
Ulti-Med Intl., Inc.
General Hospital · 108d
Cleared Aug 17, 1992
E.R. SUTURE TRAY, STERILE, DISPOSABLE
K920518
Trinity Laboratories, Inc.
General Hospital · 195d
Cleared Aug 13, 1992
INCISSION & DRAINAGE TRAY
K921203
Trinity Laboratories, Inc.
General Hospital · 154d
Cleared Aug 13, 1992
DELUXE WOUND CLOSURE TRAY, STERILE, DISPOSABLE
K921204
Trinity Laboratories, Inc.
General Hospital · 154d