Product code NAE— General, Plastic Surgery
MODIFICATION TO ZENIEVA
- Classification name
- Dressing, Wound, Hydrogel Without Drug And/Or Biologic
- Device class
- Class 1
- Regulation
- 21 CFR 878.4022
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 29
- First cleared
- Most recent
Market context for product code NAE
FDA has cleared devices under product code NAE between 1980 and 2009, filed by 21 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 2009
- 2008
- 1999
- 1997
- 1996
- 1995
- 1994
- 1993
- 1992
- 1991
- 1981
- 1980
Top applicants under product code NAE
Recent clearances under product code NAE
- K083721 — MODIFICATION TO ZENIEVA
- K082865 — MODIFICATION TO ZENIEVA
- K073246 — ZENIEVA
- K992094 — GILTECH PLUS HYDROGEL SKIN DRESSING
- K991061 — DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING
- K972646 — AD-HEAL HYDROGEL DRESSING, VARIOUS SIZES
- K971597 — COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903)
- K962352 — HYDROGEL SKIN DRESSING
- K952945 — AQUAFLO HYDROGEL WOUND DRESSING & PACKER
- K951166 — BIODERM MEDICAL HYDROGEL ISLAND DRESSING
- K950412 — CURAGEL HYDROGEL WOUND DRESSING
- K945832 — BRADY MEDICAL PRODUCTS TRANSCORBENT AND THINSITE TOPICAL BORDER WOUND DRESSINGS
- K942748 — INTRASITE
- K941019 — BRADY MEDICAL PRODUCTS TRANSORBENTS WOUND DRESSING
- K934601 — NDM HYDROGAUZE WOUND DRESSING
- K935705 — ALLEVYN ISLAND WOUND DRESSING
- K935848 — BRADY MEDICAL PRODUCTS TRANSORB WOUND DRESSING
- K932336 — NU-GEL ISLAND WOUND DRESSING
- K931618 — DUODERM HYDROCOLLOID GEL
- K926508 — INTRASITE GEL
- K926202 — CLEARSITE STERILE WOUND DRESSING, NDM WOUND DRESSI
- K922666 — TRANSORB(TM) ULCER & WOUND DRESSING
- K915357 — PROMEON HYDROGEL DRESSING #45 STERILE W/O MESH
- K915359 — PROMEON HYDROGEL DRESSING #45 STERILE W/ MESH
- K915182 — DEROYAL HYDROGEL DRESSING
- K920677 — CLEARSITE HYDROGEL WOUND DRESSING MODIFICATION
- K914207 — CLEARSITE(R) STERILE WOUND CARE DRESSING
- K810902 — IP-758 BURN WOUND DRESSING
- K802793 — LOMATUELL OINTMENT DRESSING
Data sourced from openFDA. This site is unofficial and independent of the FDA.