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
145–168 of 450
Cleared Jul 12, 1990
CUSTOMED LAP PACK IV
K902031
Customed, Inc.
General Hospital · 69d
Cleared Jun 12, 1990
ABSORBABLE GAUZE DRAPE
K901465
Ulti-Med Intl., Inc.
General Hospital · 77d
Cleared Feb 13, 1990
MERCY HIP/KNEE PACK
K896215
Westmark, Sterile Packing Systems, Inc. (Sps)
General Hospital · 110d
Cleared Aug 18, 1989
OR TOWEL PACKS
K894764
Advance Medical Designs, Inc.
General Hospital · 22d
Cleared Jun 01, 1989
THERMALAP
K893212
O.R. Concepts, Inc.
General Hospital · 35d
Cleared Apr 20, 1989
SURGICAL 'LASER' DRAPE
K884231
Henley Intl.
General Hospital · 195d
Cleared Mar 14, 1989
O.R. TOWELS (STERILE)
K890709
Cypress Medical Products, Ltd.
General Hospital · 29d
Cleared Mar 03, 1989
AM TM SYRGICAL DRAPES
K882643
Henley Intl.
General Hospital · 249d
Cleared Feb 27, 1989
PMS ANGIO DRAPE
K890471
Professional Medical Services
General Hospital · 27d
Cleared Dec 17, 1987
3M BRAND LASER PROTECTION SURGICAL DRAPES, 88XX
K874086
3M Company
General Hospital · 71d
Cleared Oct 23, 1987
LASER RESISTANT DRAPE
K873141
Baxter Healthcare Corp
General Hospital · 74d
Cleared Jul 28, 1987
OPSITE SPECIALITY DRAPES
K872757
Smith & Nephew, Inc.
General Hospital · 15d
Cleared May 28, 1987
DISPOSABLE LASER PROTECTIVE DRAPE FOR CO2 LASER
K871068
Lifestream Int'L, Inc.
General Hospital · 71d
Cleared Feb 20, 1987
MODIFIED DISPOSABLE STERILE TOWEL USED IN SURGERY
K864388
Deroyal Industries, Inc.
General Hospital · 106d
Cleared Aug 07, 1986
SPUNGUARD PLUS SURGICAL DRAPE
K862801
Kimberly-Clark Corp.
General Hospital · 15d
Cleared Jun 04, 1986
STERILE TOWEL W/ANTIMICROBIAL AGENT
K861969
Deroyal Industries, Inc.
General Hospital · 15d
Cleared Apr 30, 1986
STERILE STOCKINETTE W/ANTIMICROBIAL AGENT
K861196
Deroyal Industries, Inc.
General Hospital · 30d
Cleared Apr 04, 1986
ABSORBENT, FIBER, OPERATING ROOM TOWELS
K860936
Ulti-Med Intl., Inc.
General Hospital · 23d
Cleared Feb 21, 1986
TUBULAR ORTHO. STOCKINETTE W/ANTIMICROBIAL AGENT
K860326
Deroyal Industries, Inc.
General Hospital · 23d
Cleared Feb 19, 1986
100% COTTON ABSORBENT TOWEL
K860248
Devon Industries, Inc.
General Hospital · 26d
Cleared Feb 19, 1986
STANGUARD O.R. TOWEL PACK-4TOWEL PACK #278220400
K860447
Standard Textile Co., Inc.
General Hospital · 15d
Cleared May 01, 1985
ABCO DRAPES/TOWELS
K851314
Abco Dealers, Inc.
General Hospital · 29d
Cleared Jan 14, 1985
SURGICAL DRAPES
K844802
Procter & Gamble Mfg. Co.
General Hospital · 34d
Cleared Jan 10, 1985
I.V. START KIT & OBSTETRICAL KIT
K843724
E.M. Adams
General Hospital · 108d