KOZ · Class I · 21 CFR 878.4018

FDA Product Code KOZ: Beads, Hydrophilic, For Wound Exudate Absorption

Leading manufacturers include Smith & Nephew United, Inc., Marion Laboratories, Inc. and Pharmaseal Laboratories.

22
Total
22
Cleared
110d
Avg days
1976
Since

FDA 510(k) Cleared Beads, Hydrophilic, For Wound Exudate Absorption Devices (Product Code KOZ)

22 devices
1–22 of 22
Cleared Apr 12, 1991
INCARE PINSITE DRESSING
K905206
Hollister, Inc.
General & Plastic Surgery · 143d
Cleared Apr 01, 1991
CUTINOVA HYDRO
K905688
Beiersdorf, Inc.
General & Plastic Surgery · 103d
Cleared Jan 31, 1991
IODOSORB GEL
K905069
Perstorp AB C/O Robert Joel Slomoff
General & Plastic Surgery · 83d
Cleared Jan 07, 1991
REDI-RELEASE ABSORBENT DRESSING
K904604
Fountain Pharmaceuticals, Inc.
General & Plastic Surgery · 89d
Cleared Nov 21, 1990
BIOCLUSIVE(R) ABSORBENT DRESSING
K896828
Johnson & Johnson International
General & Plastic Surgery · 352d
Cleared Nov 21, 1990
DERMASORB WOUND CONTACT LAYER DRESSING
K903645
Convatec, A Division of E.R. Squibb & Sons
General & Plastic Surgery · 99d
Cleared Oct 23, 1990
ALLEVYN DRESSING CLAIMS CHANGE
K904412
Smith & Nephew United, Inc.
General & Plastic Surgery · 27d
Cleared Jun 28, 1990
INTRASITE CAVITY WOUND DRESSING (LABEL REVISION)
K901876
Smith & Nephew United, Inc.
General & Plastic Surgery · 63d
Cleared Nov 24, 1989
EXUSORB(TM) DRY/WET DRESSING
K896176
Controlled Therapeutics Corp.
General & Plastic Surgery · 30d
Cleared Nov 07, 1989
INTRASITE CAVITY WOUND DRESSING
K895354
Smith & Nephew United, Inc.
General & Plastic Surgery · 67d
Cleared Jan 22, 1988
ENVISAN PAD
K874552
Marion Laboratories, Inc.
General & Plastic Surgery · 79d
Cleared Jan 14, 1988
DEBRISAN ABSORBENT PAD
K872453
Pharmacia, Inc.
General & Plastic Surgery · 205d
Cleared Dec 18, 1987
ENVISAN PASTE
K874553
Marion Laboratories, Inc.
General & Plastic Surgery · 44d
Cleared Jul 24, 1987
DEXTRANOMER
K872117
Interworld, Inc.
General & Plastic Surgery · 53d
Cleared Mar 27, 1987
PHARMASEAL WOUND CARE DRESSING PAD
K870941
American Pharmaseal Div. Ahsc
General & Plastic Surgery · 18d
Cleared Mar 20, 1987
IODOSORB POWDER
K870559
Perstorp AB C/O Robert Joel Slomoff
General & Plastic Surgery · 38d
Cleared Jan 16, 1985
BIPORE O.2 MICRON HYDROPHOBIC FILTER ASSEMBLY
K844625
Bipore, Inc.
General & Plastic Surgery · 50d
Cleared Nov 08, 1984
COMFEEL POWDER
K834343
Coloplast A/S
General & Plastic Surgery · 332d
Cleared Apr 21, 1982
HOLLISTER WOUND EXUDATE ABSORBER
K820160
Hollister, Inc.
General & Plastic Surgery · 91d
Cleared Aug 04, 1980
DEBRISAN (DEXTRANOMER) PASTE
K800737
Pharmaseal Laboratories
General & Plastic Surgery · 124d
Cleared Nov 30, 1978
MEDICAL PROTEIN HYDROLYSATE REVITAL
K780775
Robertson Resources, Inc.
General & Plastic Surgery · 210d
Cleared Dec 16, 1976
CLEANSING AGENT, NEW WOUND (DEBRISSU)
K760469
Pharmaseal Laboratories
General & Plastic Surgery · 119d

About Product Code KOZ - Regulatory Context