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
49–72 of 705
Cleared Nov 10, 2023
Skin and Wound Cleanser
K231564
Winner Medical Co., Ltd.
General & Plastic Surgery · 163d
Cleared Oct 26, 2023
Antimicrobial Gelling Fiber Dressing with PHMB
K213473
Advanced Medical Solutions, Ltd.
General & Plastic Surgery · 728d
Cleared Oct 13, 2023
APIS (R), VERIS (TM)
K222143
Sweetbio, Inc.
General & Plastic Surgery · 450d
Cleared Oct 11, 2023
G4Derm / G4Derm Plus Synthetic Wound Matrix
K222025
Gel4med, Inc.
General & Plastic Surgery · 457d
Cleared Sep 29, 2023
Antibacterial bandage
K221570
Allmed Medical Products Co., Ltd.
General & Plastic Surgery · 486d
Cleared Aug 18, 2023
ALLEVYN Ag+ Border Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Border Sacrum Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Surgical Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing
K223526
Smith & Nephew Medical Limited
General & Plastic Surgery · 268d
Cleared Jun 21, 2023
Antibacterial Bandage
K221311
Winner Medical Co., Ltd.
General & Plastic Surgery · 412d
Cleared May 24, 2023
coactiv+™ Antimicrobial Wound Gel
K223259
Kane Biotech, Inc.
General & Plastic Surgery · 212d
Cleared Apr 05, 2023
Antimicrobial Silicone PHMB Foam Wound Dressing
K223310
Advanced Medical Solutions Limited
General & Plastic Surgery · 159d
Cleared Mar 30, 2023
BIASURGE Advanced Surgical Solution
K223377
Rochal Technologies, LLC
General & Plastic Surgery · 146d
Cleared Mar 16, 2023
Sterile Silver Alginate Wound Dressing
K220673
Qingdao Bright Moon Biomedical Materials Co., Ltd.
General & Plastic Surgery · 374d
Cleared Jan 30, 2023
PHMB Wound Dressing
K221532
Winner Medical Co., Ltd.
General & Plastic Surgery · 249d
Cleared Jan 17, 2023
Ag Foam Dressing Non-Adhesive (OTC)
K221754
Winner Medical Co., Ltd.
General & Plastic Surgery · 215d
Cleared Jan 13, 2023
Spectricept Skin and Wound Cleanser
K213514
Spectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc.
General & Plastic Surgery · 437d
Cleared Jan 13, 2023
Antimicrobial gauze sponge dressing
K221755
Winner Medical Co., Ltd.
General & Plastic Surgery · 211d
Cleared Dec 21, 2022
ELECTROCYN soma
K220286
V3Bio Sdn. Bhd
General & Plastic Surgery · 323d
Cleared Dec 21, 2022
Extra Silver Gelling Fiber Dressing
K221720
Winner Medical Co., Ltd.
General & Plastic Surgery · 191d
Cleared Oct 26, 2022
Silverlon Wound Contact, Burn Contact Dressings
K221218
Argentum Medical, Inc.
General & Plastic Surgery · 182d
Cleared Oct 18, 2022
MEBO Wound Dressing
K222657
Mebo Life Science, Inc.
General & Plastic Surgery · 46d
Cleared Aug 19, 2022
Bonvadis Topical Cream
K212554
Stemcyte, Inc.
General & Plastic Surgery · 371d
Cleared Apr 22, 2022
LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel
K211123
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery · 372d
Cleared Mar 23, 2022
LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber Dressing
K210718
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery · 378d
Cleared Feb 24, 2022
PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing
K210135
3M Healthcare Business Group
General & Plastic Surgery · 401d
Cleared Jan 14, 2022
Silver Gelling Fiber Dressing
K210466
Winner Medical Co., Ltd.
General & Plastic Surgery · 332d