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

707
Total
707
Cleared
187d
Avg days
1978
Since
707 devices
361–384 of 707
Cleared May 04, 1998
DUMEX PAK-ITS-ABSORBASALT COTTON GAUZE PACKING
K980777
Dumex Medical Surgical Products, Ltd.
General & Plastic Surgery · 63d
Cleared Mar 05, 1998
20 ML NORMAL SALINE TOPICAL SOLUTION, 0.9% W/V SODIUM CHLORIDE
K972185
Steripak, Ltd.
General & Plastic Surgery · 268d
Cleared Feb 13, 1998
ALGOPLAQUE FILM EXTRA THIN HYDROCOLLOID DRESSING
K974348
Laboratoires Urgo S.A.
General & Plastic Surgery · 86d
Cleared Dec 23, 1997
DUODERM CONTROL GEL FORMULA BORDER DRESSING
K973688
Convatec, Ltd.
General & Plastic Surgery · 88d
Cleared Dec 23, 1997
DUODERM HYDROACTIVE DRESSING
K973689
Convatec, Ltd.
General & Plastic Surgery · 88d
Cleared Dec 23, 1997
DUODERM HYDROACTIVE PASTE
K973807
Convatec, A Bristol-Myers Squibb Co.
General & Plastic Surgery · 78d
Cleared Dec 22, 1997
DUODERM CGF CONTROL GEL FORMULA DRESSING
K973632
Convatec, A Division of E.R. Squibb & Sons
General & Plastic Surgery · 89d
Cleared Dec 17, 1997
DUODERM EXTRA THIN CGF DRESSING
K973716
Convatec, A Bristol-Myers Squibb Co.
General & Plastic Surgery · 79d
Cleared Dec 17, 1997
COMBIDERM ACD
K973717
Convatec, A Bristol-Myers Squibb Co.
General & Plastic Surgery · 79d
Cleared Dec 16, 1997
KENDALL CURITY PETROLATUM GAUZE
K973511
Kendall Healthcare Products Co. Div.Of Tyco Health
General & Plastic Surgery · 90d
Cleared Dec 15, 1997
KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317)
K973507
Kendall Healthcare Products Co. Div.Of Tyco Health
General & Plastic Surgery · 90d
Cleared Dec 01, 1997
IT HYDROCOLLOID WITH ZINC
K973855
Innovative Technologies , Ltd.
General & Plastic Surgery · 53d
Cleared Jul 29, 1997
ARGLAES FILM DRESSING
K970566
Maersk Medical, Ltd.
General & Plastic Surgery · 166d
Cleared Jun 24, 1997
HYDROCOLLOID WOUND DRESSINGS
K971126
Innovative Technologies , Ltd.
General & Plastic Surgery · 89d
Cleared Feb 07, 1997
MITRAFLEX PIGMENTED WOUND DRESSING
K964701
Polymedica Industries, Inc.
General & Plastic Surgery · 74d
Cleared Sep 23, 1996
SURESKIN STANDARD, BORDER, AND THIN
K963039
Euromed A/S
General & Plastic Surgery · 49d
Cleared Sep 20, 1996
SIGNALDRESS
K962590
Convatec, A Division of E.R. Squibb & Sons
General & Plastic Surgery · 80d
Cleared Nov 29, 1995
TECNOL SALINE WET DRESSING
K954243
Tecnol Medical Products, Inc.
General & Plastic Surgery · 79d
Cleared Nov 02, 1995
DERMAGRAN HYDROPHILIC OINTMENT
K954739
Derma Sciences, Inc.
General & Plastic Surgery · 17d
Cleared Nov 02, 1995
DERMAGRAN WOUND DRESSING
K954740
Derma Sciences, Inc.
General & Plastic Surgery · 17d
Cleared Nov 02, 1995
DERMAGRAN WET DRESSING (ZINC-SALINE)
K954742
Derma Sciences, Inc.
General & Plastic Surgery · 17d
Cleared Nov 02, 1995
DERMAGRAN WOUND DRESSING CLEANER W/ZINC
K954743
Derma Sciences, Inc.
General & Plastic Surgery · 17d
Cleared Oct 23, 1995
RECLOSABLE WOUND COVER
K954621
Hollister, Inc.
General & Plastic Surgery · 18d
Cleared Oct 06, 1995
HOLLISTER HYDROCOLLOID WOUND DRESSING
K954235
Hollister, Inc.
General & Plastic Surgery · 25d