KOZ · Beads, Hydrophilic, For Wound Exudate Absorption
General, Plastic Surgery · 21 CFR 878.4018 · Class 1
Overview
| Product Code | KOZ |
|---|---|
| Device Name | Beads, Hydrophilic, For Wound Exudate Absorption |
| Regulation | 21 CFR 878.4018 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
Identification
A hydrophilic wound dressing is a sterile or non-sterile device intended to cover a wound and to absorb exudate. It consists of nonresorbable materials with hydrophilic properties that are capable of absorbing exudate (e.g., cotton, cotton derivatives, alginates, dextran, and rayon). This classification does not include a hydrophilic wound dressing that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter subject to the limitations in § 878.9.
Recent Cleared Devices (20 of 22)
Showing 20 most recent of 22 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K905206 | INCARE PINSITE DRESSING | Hollister, Inc. | Apr 12, 1991 | SESE |
| K905688 | CUTINOVA HYDRO | Beiersdorf, Inc. | Apr 1, 1991 | SESE |
| K905069 | IODOSORB GEL | Perstorp AB C/O Robert Joel Slomoff | Jan 31, 1991 | SESE |
| K904604 | REDI-RELEASE ABSORBENT DRESSING | Fountain Pharmaceuticals, Inc. | Jan 7, 1991 | SESE |
| K903645 | DERMASORB WOUND CONTACT LAYER DRESSING | Convatec, A Division of E.R. Squibb & Sons | Nov 21, 1990 | SESE |
| K896828 | BIOCLUSIVE(R) ABSORBENT DRESSING | Johnson & Johnson International | Nov 21, 1990 | SESE |
| K904412 | ALLEVYN DRESSING CLAIMS CHANGE | Smith & Nephew United, Inc. | Oct 23, 1990 | SN |
| K901876 | INTRASITE CAVITY WOUND DRESSING (LABEL REVISION) | Smith & Nephew United, Inc. | Jun 28, 1990 | SN |
| K896176 | EXUSORB(TM) DRY/WET DRESSING | Controlled Therapeutics Corp. | Nov 24, 1989 | SESE |
| K895354 | INTRASITE CAVITY WOUND DRESSING | Smith & Nephew United, Inc. | Nov 7, 1989 | SN |
| K874552 | ENVISAN PAD | Marion Laboratories, Inc. | Jan 22, 1988 | SN |
| K872453 | DEBRISAN ABSORBENT PAD | Pharmacia, Inc. | Jan 14, 1988 | SN |
| K874553 | ENVISAN PASTE | Marion Laboratories, Inc. | Dec 18, 1987 | SN |
| K872117 | DEXTRANOMER | Interworld, Inc. | Jul 24, 1987 | SN |
| K870941 | PHARMASEAL WOUND CARE DRESSING PAD | American Pharmaseal Div. Ahsc | Mar 27, 1987 | SESE |
| K870559 | IODOSORB POWDER | Perstorp AB C/O Robert Joel Slomoff | Mar 20, 1987 | SN |
| K844625 | BIPORE O.2 MICRON HYDROPHOBIC FILTER ASSEMBLY | Bipore, Inc. | Jan 16, 1985 | SESE |
| K834343 | COMFEEL POWDER | Coloplast A/S | Nov 8, 1984 | SESE |
| K820160 | HOLLISTER WOUND EXUDATE ABSORBER | Hollister, Inc. | Apr 21, 1982 | SESE |
| K800737 | DEBRISAN (DEXTRANOMER) PASTE | Pharmaseal Laboratories | Aug 4, 1980 | SESE |
Top Applicants
- Smith & Nephew United, Inc. — 3 clearances
- Hollister, Inc. — 2 clearances
- Marion Laboratories, Inc. — 2 clearances
- Perstorp AB C/O Robert Joel Slomoff — 2 clearances
- Pharmaseal Laboratories — 2 clearances
