NAE · Class I · 21 CFR 878.4022

FDA Product Code NAE: Dressing, Wound, Hydrogel Without Drug And/or Biologic

Leading manufacturers include Smith & Nephew United, Inc., Medtronic Vascular and Convatec, A Division of E.R. Squibb & Sons.

29
Total
29
Cleared
110d
Avg days
1980
Since

FDA 510(k) Cleared Dressing, Wound, Hydrogel Without Drug And/or Biologic Devices (Product Code NAE)

29 devices
1–24 of 29
Cleared Jul 29, 1997
COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903)
K971597
Coloplast Corp.
General & Plastic Surgery · 89d
Cleared Aug 23, 1995
AQUAFLO HYDROGEL WOUND DRESSING & PACKER
K952945
Sherwood Medical Co.
General & Plastic Surgery · 58d
Cleared Mar 24, 1995
CURAGEL HYDROGEL WOUND DRESSING
K950412
Kendall Healthcare Products Co. Div.Of Tyco Health
General & Plastic Surgery · 52d
Cleared Jun 29, 1994
INTRASITE
K942748
Smith & Nephew United, Inc.
General & Plastic Surgery · 19d
Cleared Feb 15, 1994
ALLEVYN ISLAND WOUND DRESSING
K935705
Smith & Nephew United, Inc.
General & Plastic Surgery · 77d
Cleared Feb 09, 1994
NU-GEL ISLAND WOUND DRESSING
K932336
Johnson & Johnson Medical, Inc.
General & Plastic Surgery · 271d
Cleared Dec 10, 1993
DUODERM HYDROCOLLOID GEL
K931618
Convatec, A Division of E.R. Squibb & Sons
General & Plastic Surgery · 252d
Cleared Jul 13, 1993
INTRASITE GEL
K926508
Smith & Nephew United, Inc.
General & Plastic Surgery · 195d
Cleared May 28, 1992
PROMEON HYDROGEL DRESSING #45 STERILE W/O MESH
K915357
Medtronic Vascular
General & Plastic Surgery · 183d
Cleared May 28, 1992
PROMEON HYDROGEL DRESSING #45 STERILE W/ MESH
K915359
Medtronic Vascular
General & Plastic Surgery · 183d
Cleared Apr 21, 1992
DEROYAL HYDROGEL DRESSING
K915182
Deroyal Industries, Inc.
General & Plastic Surgery · 158d

About Product Code NAE - Regulatory Context