KOZ — Beads, Hydrophilic, For Wound Exudate Absorption Class I
FDA product code KOZ covers "Beads, Hydrophilic, For Wound Exudate Absorption", a Class I medical device regulated under 21 CFR 878.4018. Submissions are reviewed by the General, Plastic Surgery panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KOZ
- Device Class
- Class I
- Regulation Number
- 878.4018
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K905206 | hollister | INCARE PINSITE DRESSING | April 12, 1991 |
| K905688 | beiersdorf | CUTINOVA HYDRO | April 1, 1991 |
| K905069 | perstorp ab c/o robert joel slomoff | IODOSORB GEL | January 31, 1991 |
| K904604 | fountain pharmaceuticals | REDI-RELEASE ABSORBENT DRESSING | January 7, 1991 |
| K896828 | johnson and johnson international | BIOCLUSIVE(R) ABSORBENT DRESSING | November 21, 1990 |
| K903645 | convatec, a division of e.r. squibb and sons | DERMASORB WOUND CONTACT LAYER DRESSING | November 21, 1990 |
| K904412 | smith and nephew united | ALLEVYN DRESSING CLAIMS CHANGE | October 23, 1990 |
| K901876 | smith and nephew united | INTRASITE CAVITY WOUND DRESSING (LABEL REVISION) | June 28, 1990 |
| K896176 | controlled therapeutics | EXUSORB(TM) DRY/WET DRESSING | November 24, 1989 |
| K895354 | smith and nephew united | INTRASITE CAVITY WOUND DRESSING | November 7, 1989 |
| K874552 | marion laboratories | ENVISAN PAD | January 22, 1988 |
| K872453 | pharmacia | DEBRISAN ABSORBENT PAD | January 14, 1988 |
| K874553 | marion laboratories | ENVISAN PASTE | December 18, 1987 |
| K872117 | interworld | DEXTRANOMER | July 24, 1987 |
| K870941 | american pharmaseal div. ahsc | PHARMASEAL WOUND CARE DRESSING PAD | March 27, 1987 |
| K870559 | perstorp ab c/o robert joel slomoff | IODOSORB POWDER | March 20, 1987 |
| K844625 | bipore | BIPORE O.2 MICRON HYDROPHOBIC FILTER ASSEMBLY | January 16, 1985 |
| K834343 | coloplast | COMFEEL POWDER | November 8, 1984 |
| K820160 | hollister | HOLLISTER WOUND EXUDATE ABSORBER | April 21, 1982 |
| K800737 | pharmaseal laboratories | DEBRISAN (DEXTRANOMER) PASTE | August 4, 1980 |