Product Code: KOZ FDA class 1 21 CFR 878.4018

Beads, Hydrophilic, For Wound Exudate Absorption

General, Plastic Surgery

This device consists of hydrophilic beads used in wound care to absorb excess exudate from wounds, supporting a moist wound environment that promotes healing. It is classified as FDA Class 1, indicating low risk and regulation through general controls without requiring premarket notification. The product code is KOZ, regulated under 21 CFR 878.4018 within the General and Plastic Surgery specialty. No special flags apply to this device.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

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Basic Information

Product Code: KOZ
Device Class: FDA class 1
Regulation Number: 878.4018
Medical Specialty: General, Plastic Surgery
Review Panel: SU
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 22 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K905206	INCARE PINSITE DRESSING	Apr 12, 1991	Substantially Equivalent	Hollister, Inc.
K905688	CUTINOVA HYDRO	Apr 01, 1991	Substantially Equivalent	Beiersdorf, Inc.
K905069	IODOSORB GEL	Jan 31, 1991	Substantially Equivalent	Perstorp AB C/O Robert Joel Slomoff
K904604	REDI-RELEASE ABSORBENT DRESSING	Jan 07, 1991	Substantially Equivalent	Fountain Pharmaceuticals, Inc.
K903645	DERMASORB WOUND CONTACT LAYER DRESSING	Nov 21, 1990	Substantially Equivalent	Convatec, A Division of E.R. Squibb & Sons
K896828	BIOCLUSIVE(R) ABSORBENT DRESSING	Nov 21, 1990	Substantially Equivalent	Johnson & Johnson International
K904412	ALLEVYN DRESSING CLAIMS CHANGE	Oct 23, 1990	Substantially Equivalent for Some Indications	Smith & Nephew United, Inc.
K901876	INTRASITE CAVITY WOUND DRESSING (LABEL REVISION)	Jun 28, 1990	Substantially Equivalent for Some Indications	Smith & Nephew United, Inc.
K896176	EXUSORB(TM) DRY/WET DRESSING	Nov 24, 1989	Substantially Equivalent	Controlled Therapeutics Corp.
K895354	INTRASITE CAVITY WOUND DRESSING	Nov 07, 1989	Substantially Equivalent for Some Indications	Smith & Nephew United, Inc.
K874552	ENVISAN PAD	Jan 22, 1988	Substantially Equivalent for Some Indications	Marion Laboratories, Inc.
K872453	DEBRISAN ABSORBENT PAD	Jan 14, 1988	Substantially Equivalent for Some Indications	Pharmacia, Inc.
K874553	ENVISAN PASTE	Dec 18, 1987	Substantially Equivalent for Some Indications	Marion Laboratories, Inc.
K872117	DEXTRANOMER	Jul 24, 1987	Substantially Equivalent for Some Indications	Interworld, Inc.
K870941	PHARMASEAL WOUND CARE DRESSING PAD	Mar 27, 1987	Substantially Equivalent	American Pharmaseal Div. Ahsc
K870559	IODOSORB POWDER	Mar 20, 1987	Substantially Equivalent for Some Indications	Perstorp AB C/O Robert Joel Slomoff
K844625	BIPORE O.2 MICRON HYDROPHOBIC FILTER ASSEMBLY	Jan 16, 1985	Substantially Equivalent	Bipore, Inc.
K834343	COMFEEL POWDER	Nov 08, 1984	Substantially Equivalent	Coloplast A/S
K820160	HOLLISTER WOUND EXUDATE ABSORBER	Apr 21, 1982	Substantially Equivalent	Hollister, Inc.
K800737	DEBRISAN (DEXTRANOMER) PASTE	Aug 04, 1980	Substantially Equivalent	Pharmaseal Laboratories
K780775	MEDICAL PROTEIN HYDROLYSATE REVITAL	Nov 30, 1978	Substantially Equivalent	Robertson Resources, Inc.
K760469	CLEANSING AGENT, NEW WOUND (DEBRISSU)	Dec 16, 1976	Substantially Equivalent	Pharmaseal Laboratories