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 Derma Sciences, Inc..

707
Total
707
Cleared
187d
Avg days
1978
Since
707 devices
385–408 of 707
Cleared Aug 16, 1995
SALINE DRESSING
K952948
Busse Hospital Disposables, Inc.
General & Plastic Surgery · 51d
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 Dec 10, 1993
SPYROFILM IQ WOUND DRESSING(WITH INERT FILLER)
K932676
Polymedica Industries, Inc.
General & Plastic Surgery · 191d
Cleared Nov 24, 1993
SALINE WET DRESSING- STERILE
K934258
Trinity Laboratories, Inc.
General & Plastic Surgery · 85d
Cleared May 27, 1993
DERMAGRAN WOUND DRESSING
K924754
Derma Sciences, Inc.
General & Plastic Surgery · 246d
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 Jun 06, 1990
WOUND TREATMENT KIT
K901109
Orion Life Systems, Inc.
General & Plastic Surgery · 89d
Cleared Jan 03, 1990
SILASTIC SOFT SHEETING
K894226
Dow Corning Wright
General & Plastic Surgery · 198d
Cleared Aug 23, 1989
KALTOCARB WOUND DRESSING
K894347
Calgon Vestal Div.
General & Plastic Surgery · 40d
Cleared Aug 09, 1989
INTRASITE* GEL (3) YEAR SHELF LIFE
K891870
Smith & Nephew United, Inc.
General & Plastic Surgery · 152d
Cleared Jul 14, 1989
KALTOSTAT WOUND PACKING
K892868
Calgon Vestal Div.
General & Plastic Surgery · 86d
Cleared Jun 23, 1989
KALTOSTAT(TM) WOUND DRESSING
K892364
Calgon Vestal Div.
General & Plastic Surgery · 78d
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 Jun 05, 1989
WATER JEL STERILE GEL-SOAKED BURN DRESSING
K892360
Pfizer, Inc.
General & Plastic Surgery · 60d
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 Oct 05, 1988
SKINCOTE
K882567
Dynarex Corp.
General & Plastic Surgery · 105d
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