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
169–192 of 705
Cleared Sep 25, 1991
INCARE HOT/ICE ABSORBENT INTERFACE
K913035
Hollister, Inc.
General & Plastic Surgery · 78d
Cleared Jan 25, 1991
DUODERM DRESSINGS, CGF DRESSINGS, PASTE FULL THICK
K904852
Convatec, A Division of E.R. Squibb & Sons
General & Plastic Surgery · 88d
Cleared Jan 03, 1990
SILASTIC SOFT SHEETING
K894226
Dow Corning Wright
General & Plastic Surgery · 198d
Cleared Jun 13, 1989
CUTINOVA(R) PLUS ON VASCULAR STASIS ULCERS
K885279
Beiersdorf, Inc.
General & Plastic Surgery · 172d
Cleared Jun 09, 1989
TEGASORB(TM) ULCER DRESSING, #90-XXX
K891288
3M Company
General & Plastic Surgery · 91d
Cleared May 05, 1989
ACTIDERM*-OPAQUE
K892232
Convatec, A Division of E.R. Squibb & Sons
General & Plastic Surgery · 31d
Cleared Mar 03, 1989
PHARMACLENS LOW ABRASION WOUND SPONGE/BRUSH
K885045
Baxter Healthcare Corp
General & Plastic Surgery · 88d
Cleared Dec 27, 1988
PHARMASEAL STERILE WOUND CARE DRESSING
K884397
Baxter Healthcare Corp
General & Plastic Surgery · 69d
Cleared Sep 22, 1988
COMPEED ATHLETIC DRESSING
K883588
Coloplast A/S
General & Plastic Surgery · 31d
Cleared Jun 22, 1988
HYDROCOLLOID DRESSING FOR PSORIASIS
K881039
Hollister, Inc.
General & Plastic Surgery · 103d
Cleared Apr 28, 1988
DUODERM(R) HYDROACTIVE(R) PASTE
K881302
Convatec, A Division of E.R. Squibb & Sons
General & Plastic Surgery · 31d
Cleared Apr 01, 1988
TEGASORB ULCER DRESSING #90-XXX
K872298
3M Company
General & Plastic Surgery · 291d
Cleared Mar 21, 1988
AIRSTRIP* WATERPROOF FIRST AID DRESS/POST-OPERA.
K881048
Smith & Nephew, Inc.
General & Plastic Surgery · 10d
Cleared Feb 22, 1988
DERMATOLOGICAL PATCH
K872926
Convatec, A Division of E.R. Squibb & Sons
General & Plastic Surgery · 210d
Cleared Nov 17, 1987
COMFEEL ULCUS ULCER CARE SYSTEM
K873669
Coloplast A/S
General & Plastic Surgery · 67d
Cleared Jul 29, 1987
INTRASITE INTERACTIVE HYDROCOLLOID WOUND DRESSING
K872624
Smith & Nephew, Inc.
General & Plastic Surgery · 23d
Cleared Jul 24, 1987
CUTINOVA(R) PLUS FOAM GELFILM
K864913
Beiersdorf, Inc.
General & Plastic Surgery · 220d
Cleared Jun 26, 1987
AMERICAN PHARMASEAL WOUND DRESSING
K871770
American Pharmaseal Div. Ahsc
General & Plastic Surgery · 51d
Cleared Dec 01, 1986
VISCOPASTE ZINC PASTE BANDAGE
K863930
Smith & Nephew, Inc.
General & Plastic Surgery · 54d
Cleared Sep 30, 1986
HYDROCOLLOID DRESSINGS - STERILE
K863390
Convatec, A Division of E.R. Squibb & Sons
General & Plastic Surgery · 27d
Cleared Aug 04, 1986
HOLLISTER WOUND CARE BARRIER
K862572
Hollister, Inc.
General & Plastic Surgery · 28d
Cleared Jul 09, 1986
JOHNSON & JOHNSON PETROLATUM GAUZE NON ADHER DRESS
K862163
Johnson & Johnson Professionals, Inc.
General & Plastic Surgery · 33d
Cleared Jul 01, 1986
NON-ADHERING DRESSING WITH POVIDONE-IODINE
K861384
Johnson & Johnson Professionals, Inc.
General & Plastic Surgery · 78d
Cleared Apr 10, 1986
BARD ABSORPTION DRESSING
K861024
C.R. Bard, Inc.
General & Plastic Surgery · 23d