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
73–96 of 450
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 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 Jun 11, 1984
SPUNGARD & SURG. DRAPES-GOWNS & PACKS
K842115
Kimberly-Clark Corp.
General Hospital · 47d
Cleared Jan 25, 1984
SINGLE-USE SURGICAL DRAPES
K833877
Procter & Gamble Mfg. Co.
General Hospital · 78d
Cleared Sep 29, 1983
LIGHT HANDLE COVER
K832278
Concept, Inc.
General Hospital · 79d
Cleared Jan 07, 1983
GORE-TEX BARRIER SURG. DRAPES & GOWNS
K822641
W.L. Gore & Associates, Inc.
General Hospital · 128d
Cleared Jul 22, 1982
BARRIER ANTIMICROBIAL INCISE DRAPE
K820543
Surgikos, Inc.
General Hospital · 142d
Cleared Jun 02, 1982
SURGIKOS INCISE DRAPE
K820542
Surgikos, Inc.
General Hospital · 92d
Cleared May 12, 1982
CURITY PREMIUM CYSTOSCOPY TRAY
K820850
The Kendal Co.
General Hospital · 47d
Cleared Mar 10, 1982
ANAGO STERILE PRODUCTS
K813097
Anago, Inc.
General Hospital · 127d
Cleared Nov 06, 1981
STERILE ADHERENT DRAPES
K812809
Abco Dealers, Inc.
General Hospital · 31d
Cleared Sep 17, 1981
3M GERMICIDAL SURGICAL INCISE DRAPE
K801550
3M Company
General Hospital · 441d
Cleared Aug 20, 1981
BACTERICIDAL INCISE DRAPE
K811871
Surgikos, Inc.
General Hospital · 50d
Cleared Aug 13, 1981
GATOR DRAPES
K811996
The Anspach Effort, Inc.
General Hospital · 29d
Cleared Dec 19, 1980
DISPOSABLE STERILE LAP SPONGE
K802980
Anago, Inc.
General Hospital · 25d
Cleared Nov 12, 1980
BOUNDARY SURGICAL DRAPES WITH ADHESIVE
K802652
Procter & Gamble Mfg. Co.
General Hospital · 19d
Cleared Oct 10, 1980
WHITE KNIGHT BOVIE CORD/SUCTION TUBE
K802213
G.D. Searle and Co.
General Hospital · 28d
Cleared Oct 10, 1980
WHITE KNIGHT DRAPE SEAL
K802280
G.D. Searle and Co.
General Hospital · 22d
Cleared Sep 26, 1980
BOUNDARY SINGLE-USE DRAPE
K802148
Procter & Gamble Mfg. Co.
General Hospital · 18d
Cleared Sep 26, 1980
BOUNDARY SINGLE-USE DRAPES
K802192
Procter & Gamble Mfg. Co.
General Hospital · 16d
Cleared Sep 26, 1980
BOUNDARY SINGLE-USE DRAPES
K802247
Procter & Gamble Mfg. Co.
General Hospital · 10d
Cleared Aug 20, 1980
BARRIER TOWEL DRAPE
K801863
Surgikos, Inc.
General Hospital · 15d