FRO

FDA Product Code FRO: Dressing, Wound, Drug

FDA product code FRO covers drug-eluting wound dressings that combine a wound contact layer with an active pharmaceutical ingredient.

These dressings deliver antimicrobial agents, growth factors, or analgesics directly to the wound bed while maintaining a moist healing environment. The drug component provides local therapeutic activity beyond the mechanical protection of a standard dressing.

FRO devices are reviewed by the FDA General & Plastic Surgery panel.

Leading manufacturers include Convatec, A Division of E.R. Squibb & Sons, Winner Medical Co., Ltd. and Huizhou Foryou Medical Devices Co., Ltd..

705
Total
705
Cleared
187d
Avg days
1978
Since
705 devices
121–144 of 705
Cleared Jul 02, 2018
Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP
K173276
Medline Industries, Inc.
General & Plastic Surgery · 263d
Cleared May 11, 2018
ALGS6 Ag Alginate Wound Dressing
K172570
Foshan United Medical Technologies, Ltd.
General & Plastic Surgery · 256d
Cleared May 01, 2018
LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial Alginate Dressing
K172554
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery · 250d
Cleared Apr 27, 2018
HYALURONIC ACID TOPICAL WOUND CREAM
K172747
Virchow Biotech Pvt, Ltd.
General & Plastic Surgery · 227d
Cleared Apr 13, 2018
Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC)
K180305
Aquilabs Us, LLC
General & Plastic Surgery · 70d
Cleared Apr 04, 2018
Algidex Ag Silver Alginate Wound Dressing
K173072
Deroyal Industries, Inc.
General & Plastic Surgery · 187d
Cleared Apr 02, 2018
Microcyn Antimicrobial Hydrogel
K173896
Sonoma Pharmaceuticals, Inc.
General & Plastic Surgery · 101d
Cleared Feb 21, 2018
Catasyn Advanced Technology Wound Hydrogel
K172338
Synedgen, Inc.
General & Plastic Surgery · 203d
Cleared May 23, 2017
Prontosan Wound Gel
K163430
B.Braun Medical, Inc.
General & Plastic Surgery · 167d
Cleared Nov 10, 2016
Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mL
K161623
B.Braun Medical, Inc.
General & Plastic Surgery · 150d
Cleared Oct 08, 2013
PRONTOSAN WOUND GEL X
K130857
B.Braun Medical, Inc.
General & Plastic Surgery · 194d
Cleared Feb 28, 2013
3M TEGADERM CHG CHLORHEXIDINE GLUCONATE I.V. PORT DRESSING
K123679
3M Company
General & Plastic Surgery · 90d
Cleared Apr 12, 2012
CURAD ANTIBACTERIAL BANDAGE
K113583
Medline Industries, Inc.
General & Plastic Surgery · 129d
Cleared Apr 05, 2012
BIATAIN SILICONE AG FOAM DRESSING - ADHESIVE: 3X3 INCHES, 4X4 INCHES, & 5X5 INCHES
K120828
Coloplast A/S
General & Plastic Surgery · 17d
Cleared Dec 07, 2011
3M TEGADERM MATRIX DRESSING
K110457
3M Company
General & Plastic Surgery · 293d
Cleared May 02, 2011
DURAFIBER AG
K103793
Smith & Nephew, Inc.
General & Plastic Surgery · 126d
Cleared Apr 06, 2011
PRONTOSAN WOUND IRRIGATION SOLUTION
K110744
B.Braun Medical, Inc.
General & Plastic Surgery · 20d
Cleared Nov 03, 2010
PRONTOSAN ANTIMICROBIAL WOUND GEL
K101882
B.Braun Medical, Inc.
General & Plastic Surgery · 120d
Cleared Feb 17, 2010
BIATAIN AGFOAM DRESSINGS-NON-ADHESIV: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM
K100218
Coloplast A/S
General & Plastic Surgery · 22d
Cleared Jan 07, 2010
MEDLINE CURAD WOUND DRESSINGS
K093349
Medline Industries, Inc.
General & Plastic Surgery · 72d
Cleared Jul 22, 2009
ACTICOAT FLEX 7 DRESSING
K083113
Smith & Nephew, Inc.
General & Plastic Surgery · 274d
Cleared Apr 08, 2009
PROWICK
K083007
Arthrex, Inc.
General & Plastic Surgery · 182d
Cleared Mar 17, 2009
PRONTOSAN ANTIMICROBIAL WOUND GEL
K090141
B.Braun Medical, Inc.
General & Plastic Surgery · 55d
Cleared Jun 19, 2008
PRONTOSAN WOUND IRRIGATION SOLUTION
K072876
B.Braun Medical, Inc.
General & Plastic Surgery · 254d