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
49–72 of 450
Cleared Feb 11, 2003
TRILAMINATE DRAPES/TIBURON
K023419
Allegiance Healthcare Corp.
General Hospital · 123d
Cleared Nov 06, 2002
DRAPES WITH ABSORBENT REINFORCEMENT
K023425
Allegiance Healthcare Corp.
General Hospital · 26d
Cleared Nov 04, 2002
MEDLINE ASEP PLUS SURGICAL DRAPES
K023432
Medline Industries, Inc.
General Hospital · 20d
Cleared Apr 15, 2002
WOUND PROTECTOR/RETRACTOR
K020435
Applied Medical Resources Corp.
General Hospital · 66d
Cleared Mar 06, 2002
TOWEL DRAPE, MODELS 4409, 4410
K012957
Dynarex Corp.
General Hospital · 183d
Cleared Oct 11, 2001
MODIFICATION TO: COMPEL SURGICAL DRAPES
K012807
Standard Textile Co., Inc.
General Hospital · 50d
Cleared Sep 18, 2001
ADVANCE MEDICAL DESIGNS FLUID POUCH
K012168
Advance Medical Designs, Inc.
General Hospital · 68d
Cleared Jul 10, 2001
SURGICAL DRAPES
K011422
Advance Medical Designs, Inc.
General Hospital · 62d
Cleared Jan 26, 2001
PATIENT DRAPE, SURGICAL
K003670
Advance Medical Designs, Inc.
General Hospital · 59d
Cleared Oct 26, 2000
NEUROTOLOGY DRAPE, MODEL TBD
K002702
Gyrus Ent LLC
General Hospital · 57d
Cleared Sep 01, 2000
EQUIPMENT DRAPES
K002508
Allegiance Healthcare Corp.
General Hospital · 17d
Cleared Jun 23, 2000
RESOLVE SURGICAL O.R. TOWELS
K001667
Allegiance Healthcare Corp.
General Hospital · 23d
Cleared Jun 09, 2000
VARIOUS STERILE AND NON-STERILE SURGICAL DRAPES, (I.E., DISPOSABLES MINOR PROCEDURE DRAPES, LARGE APERTURE DRAPES, ABSOR
K994199
Custom Medical Products, Inc.
General Hospital · 179d
Cleared Mar 17, 2000
CONVERTORS EQUIPMENT DRAPES
K000417
Allegiance Healthcare Corp.
General Hospital · 38d
Cleared Feb 04, 2000
ACUCAM INTRAORAL CAMERA SHEATHS, MODELS 023545, 601111, 300407, 601285
K994211
Dentsply Intl.
General Hospital · 52d
Cleared Jan 12, 2000
CONVERTORS SURGICAL DRAPES
K993795
Allegiance Healthcare Corp.
General Hospital · 64d
Cleared Sep 27, 1999
BROADLINE OR TOWELS
K991667
Broadline Medical Industries
General Hospital · 136d
Cleared Sep 24, 1999
SECURLINE OPERATING ROOM CAMERA DRAPE, MODEL 3600
K990253
Amba Medical , Ltd.
General Hospital · 240d
Cleared Jun 23, 1999
HAL SCOPE HOLDER SYSTEM
K991548
Noved Medical
General Hospital · 51d
Cleared Aug 11, 1998
OPERATING ROOM TOWELS
K981823
Baldur Systems Corp.
General Hospital · 81d
Cleared Jul 10, 1998
CONVERTORS TRILAMINATE DRAPES
K981818
Allegiance Healthcare Corp.
General Hospital · 49d
Cleared May 15, 1998
VARIOUS SURGICAL OR PATIENT DRAPES
K980210
Gel-Lite, LLC
General Hospital · 114d
Cleared Mar 13, 1998
MSI SURGICAL DRAPES
K974672
Medical Specialty Innovations, Inc. (Msi)
General Hospital · 88d
Cleared Feb 26, 1998
PROMAX SURGICAL DRAPES AND COVERS
K980183
Standard Textile Co., Inc.
General Hospital · 37d