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
145–168 of 705
Cleared Apr 25, 2008
PURACOL PLUS AG COLLAGEN MICROSCAFFOLD WOUND DRESSING
K071552
Medline Industries, Inc.
General & Plastic Surgery · 324d
Cleared Nov 09, 2007
PROWICK ANTIMICROBIAL POSTOPERATIVE WOUND DRESSING, SHOULDER AND KNEE, MODELS AR-1625, AR-1626
K072378
Arthrex, Inc.
General & Plastic Surgery · 77d
Cleared Aug 03, 2007
ALLEVYN AG DRESSING
K063835
Smith & Nephew, Inc.
General & Plastic Surgery · 220d
Cleared Apr 05, 2007
3M TEGADERM CHG DRESSING
K063458
3M Company
General & Plastic Surgery · 141d
Cleared Dec 16, 2005
3M TEGADERM SILVER (AG) MESH
K053256
3M Company
General & Plastic Surgery · 24d
Cleared Oct 20, 2005
MEDLINE IODOFORM PACKING STRIPS
K052720
Medline Industries, Inc.
General & Plastic Surgery · 21d
Cleared Jun 09, 2005
SILVER ANTIMICROBIAL WOUND GAUZE (SPONGE)
K042164
Medline Industries, Inc.
General & Plastic Surgery · 302d
Cleared Apr 21, 2005
ACTICOAT MOISTURE CONTROL DRESSING
K050030
Smith & Nephew, Inc.
General & Plastic Surgery · 104d
Cleared Nov 02, 2004
3M TEGADERM SILVER
K040890
3M Company
General & Plastic Surgery · 223d
Cleared May 17, 2004
CONTREET FOAM CAVITY DRESSING WITH SILVER, MODEL 9628 (2X4 IN.)
K033869
Coloplast Corp.
General & Plastic Surgery · 157d
Cleared Feb 03, 2003
CONTREET FOAM ADHESIVE/NON-ADHESIVE
K022416
Coloplast Corp.
General & Plastic Surgery · 194d
Cleared Jun 21, 2002
ABSORBENT ANTIMICROBIAL WOUND DRESSING
K013814
Convatec, A Division of E.R. Squibb & Sons
General & Plastic Surgery · 217d
Cleared Jan 28, 1999
COMPEED PSORIASIS DRESSING
K982493
Coloplast Corp.
General & Plastic Surgery · 195d
Cleared Dec 16, 1998
BIATAIN FOAM DRESSING
K983163
Coloplast Corp.
General & Plastic Surgery · 97d
Cleared Dec 16, 1998
BIATAIN FOAM ADHESIVE DRESSING
K983173
Coloplast Corp.
General & Plastic Surgery · 97d
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 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 Sep 20, 1996
SIGNALDRESS
K962590
Convatec, A Division of E.R. Squibb & Sons
General & Plastic Surgery · 80d
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
Cleared Jul 11, 1995
HOLLISTER HYDROCOLLOID WOUND DRESSINGS
K950933
Hollister, Inc.
General & Plastic Surgery · 132d
Cleared Feb 07, 1995
PREPPIES SKIN BARRIER WIPE
K945675
Kendall Healthcare Products Co. Div.Of Tyco Health
General & Plastic Surgery · 81d
Cleared Nov 24, 1993
SALINE WET DRESSING- STERILE
K934258
Trinity Laboratories, Inc.
General & Plastic Surgery · 85d