Product code KOZ
- Device name
- Beads, Hydrophilic, For Wound Exudate Absorption
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4018
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K905206 | INCARE PINSITE DRESSING | Hollister, Inc. | 1991-04-12 |
| K905688 | CUTINOVA HYDRO | Beiersdorf, Inc. | 1991-04-01 |
| K905069 | IODOSORB GEL | Perstorp AB C/O Robert Joel Slomoff | 1991-01-31 |
| K904604 | REDI-RELEASE ABSORBENT DRESSING | Fountain Pharmaceuticals, Inc. | 1991-01-07 |
| K903645 | DERMASORB WOUND CONTACT LAYER DRESSING | Convatec, A Division of E.R. Squibb & Sons | 1990-11-21 |
| K896828 | BIOCLUSIVE(R) ABSORBENT DRESSING | Johnson & Johnson International | 1990-11-21 |
| K904412 | ALLEVYN DRESSING CLAIMS CHANGE | Smith & Nephew United, Inc. | 1990-10-23 |
| K901876 | INTRASITE CAVITY WOUND DRESSING (LABEL REVISION) | Smith & Nephew United, Inc. | 1990-06-28 |
| K896176 | EXUSORB(TM) DRY/WET DRESSING | Controlled Therapeutics Corp. | 1989-11-24 |
| K895354 | INTRASITE CAVITY WOUND DRESSING | Smith & Nephew United, Inc. | 1989-11-07 |
| K874552 | ENVISAN PAD | Marion Laboratories, Inc. | 1988-01-22 |
| K872453 | DEBRISAN ABSORBENT PAD | Pharmacia, Inc. | 1988-01-14 |
| K874553 | ENVISAN PASTE | Marion Laboratories, Inc. | 1987-12-18 |
| K872117 | DEXTRANOMER | Interworld, Inc. | 1987-07-24 |
| K870941 | PHARMASEAL WOUND CARE DRESSING PAD | American Pharmaseal Div. Ahsc | 1987-03-27 |
| K870559 | IODOSORB POWDER | Perstorp AB C/O Robert Joel Slomoff | 1987-03-20 |
| K844625 | BIPORE O.2 MICRON HYDROPHOBIC FILTER ASSEMBLY | Bipore, Inc. | 1985-01-16 |
| K834343 | COMFEEL POWDER | Coloplast A/S | 1984-11-08 |
| K820160 | HOLLISTER WOUND EXUDATE ABSORBER | Hollister, Inc. | 1982-04-21 |
| K800737 | DEBRISAN (DEXTRANOMER) PASTE | Pharmaseal Laboratories | 1980-08-04 |
| K780775 | MEDICAL PROTEIN HYDROLYSATE REVITAL | Robertson Resources, Inc. | 1978-11-30 |
| K760469 | CLEANSING AGENT, NEW WOUND (DEBRISSU) | Pharmaseal Laboratories | 1976-12-16 |
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|---|---|---|---|
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| 00850048866966 | Collecule LpH | Human Biosciences Inc. | 2025-11-17 |
| 00850048866041 | Celluheal | Human Biosciences Inc. | 2023-09-28 |
| 00850048866058 | Medifil | Human Biosciences Inc. | 2023-06-19 |
| 00850048866126 | Medifil | Human Biosciences Inc. | 2023-06-19 |
| 00850048866195 | Medifil | Human Biosciences Inc. | 2023-06-19 |
| 00850048866188 | Medifil | Human Biosciences Inc. | 2023-06-19 |
| 00896005002435 | Simpurity | SAFE N' SIMPLE LLC | 2021-11-30 |
| 00896005002442 | Simpurity | SAFE N' SIMPLE LLC | 2021-11-30 |
| 06936943411150 | Huibo Medical | Henan Huibo Medical Co.,Ltd. | 2020-01-21 |
| 06936943411488 | Huibo Medical | Henan Huibo Medical Co.,Ltd. | 2020-01-21 |
| 00850004779750 | Simpurity | SAFE N' SIMPLE LLC | 2019-08-12 |
| 00850004779774 | Simpurity | SAFE N' SIMPLE LLC | 2019-08-12 |