NAE — Dressing, Wound, Hydrogel Without Drug And/Or Biologic Class I
FDA product code NAE covers "Dressing, Wound, Hydrogel Without Drug And/Or Biologic", a Class I medical device regulated under 21 CFR 878.4022. 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
- NAE
- Device Class
- Class I
- Regulation Number
- 878.4022
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K083721 | river edge pharmaceuticals | MODIFICATION TO ZENIEVA | January 8, 2009 |
| K082865 | gorbec pharmaceutical services | MODIFICATION TO ZENIEVA | October 23, 2008 |
| K073246 | gorbec pharmaceutical services | ZENIEVA | July 23, 2008 |
| K992094 | giltech plus | GILTECH PLUS HYDROGEL SKIN DRESSING | September 17, 1999 |
| K991061 | dermaphylyx | DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING | June 28, 1999 |
| K972646 | ludlow technical products | AD-HEAL HYDROGEL DRESSING, VARIOUS SIZES | August 21, 1997 |
| K971597 | coloplast | COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903) | July 29, 1997 |
| K962352 | north american sterilization and packaging | HYDROGEL SKIN DRESSING | August 2, 1996 |
| K952945 | sherwood medical | AQUAFLO HYDROGEL WOUND DRESSING & PACKER | August 23, 1995 |
| K951166 | bioderm | BIODERM MEDICAL HYDROGEL ISLAND DRESSING | June 21, 1995 |
| K950412 | kendall healthcare products co. div.of tyco health | CURAGEL HYDROGEL WOUND DRESSING | March 24, 1995 |
| K945832 | brady medical products | BRADY MEDICAL PRODUCTS TRANSCORBENT AND THINSITE TOPICAL BORDER WOUND DRESSINGS | March 1, 1995 |
| K942748 | smith and nephew united | INTRASITE | June 29, 1994 |
| K941019 | brady medical products | BRADY MEDICAL PRODUCTS TRANSORBENTS WOUND DRESSING | May 4, 1994 |
| K935705 | smith and nephew united | ALLEVYN ISLAND WOUND DRESSING | February 15, 1994 |
| K935848 | brady medical products | BRADY MEDICAL PRODUCTS TRANSORB WOUND DRESSING | February 15, 1994 |
| K934601 | ndm acquisition | NDM HYDROGAUZE WOUND DRESSING | February 15, 1994 |
| K932336 | johnson and johnson medical | NU-GEL ISLAND WOUND DRESSING | February 9, 1994 |
| K931618 | convatec, a division of e.r. squibb and sons | DUODERM HYDROCOLLOID GEL | December 10, 1993 |
| K926508 | smith and nephew united | INTRASITE GEL | July 13, 1993 |