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
73–96 of 705
Cleared Oct 19, 2021
Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use)
K202982
Winner Medical Co., Ltd.
General & Plastic Surgery · 384d
Cleared Sep 23, 2021
TorrentX Wound Wash
K203446
Next Science, LLC
General & Plastic Surgery · 304d
Cleared Sep 01, 2021
Omeza Collagen Matrix
K211972
Omeza, LLC
General & Plastic Surgery · 69d
Cleared May 12, 2021
High Performance Antimicrobial Gelling Fiber with Silver
K210974
Advanced Medical Solutions, Ltd.
General & Plastic Surgery · 41d
Cleared Apr 23, 2021
MIS Solution
K203835
Next Science, LLC
General & Plastic Surgery · 114d
Cleared Apr 14, 2021
AMSure® Single Use Saline Topical Solution
K201138
Amsino Medical, Inc.
General & Plastic Surgery · 351d
Cleared Feb 05, 2021
Antibacterial Bandage
K201324
Jiangsu Excellence Medical Supplies Co., Ltd.
General & Plastic Surgery · 263d
Cleared Jan 28, 2021
LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Antibacterial Alginate Wound Dressing (OTC use)
K201016
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery · 286d
Cleared Oct 19, 2020
anti-bacterial bandage
K200821
Planet (Suzhou) Medical Products Co., Ltd.
General & Plastic Surgery · 203d
Cleared Oct 08, 2020
SilverStream Gel
K200767
Enzysurge , Ltd.
General & Plastic Surgery · 197d
Cleared Sep 04, 2020
MEBO Wound Dressing
K193439
Mebo Life Science, Inc.
General & Plastic Surgery · 268d
Cleared Sep 04, 2020
3M Tegaderm CHG Chlorhexidine Gluconate Gel Pad
K200835
3M Company
General & Plastic Surgery · 157d
Cleared Sep 03, 2020
HaloGUARD Protective Disc with CHG
K200641
Attwill Medical Solutions
General & Plastic Surgery · 176d
Cleared Jun 17, 2020
LT Antibacterial Alginate with Silver Dressing
K192478
Zhejiang Longterm Medical Technology Co., Ltd.
General & Plastic Surgery · 281d
Cleared May 14, 2020
Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing with Border
K191819
Winner Medical Co., Ltd.
General & Plastic Surgery · 314d
Cleared May 14, 2020
PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB Foam Dressing, Silicone PHMB Foam Dressing with Border
K192463
Winner Medical Co., Ltd.
General & Plastic Surgery · 248d
Cleared May 11, 2020
PuraDERM Gel
K193085
3-D Matrix, Inc.
General & Plastic Surgery · 188d
Cleared Mar 11, 2020
AC5 Topical Gel
K190129
Arch Therapeutics, Inc.
General & Plastic Surgery · 408d
Cleared Feb 21, 2020
Biatain Silicone Ag
K191536
Coloplast A/S
General & Plastic Surgery · 256d
Cleared Feb 07, 2020
Rochal Antimicrobial Wound Gel
K192527
Rochal Industries, LLC
General & Plastic Surgery · 147d
Cleared Dec 20, 2019
IODOSORB
K190730
Smith & Nephew Medical, Ltd.
General & Plastic Surgery · 274d
Cleared Dec 20, 2019
IODOFLEX
K190756
Smith & Nephew Medical, Ltd.
General & Plastic Surgery · 270d
Cleared Nov 06, 2019
Hydrofera Blue READY - Border
K190268
Hydrofera, LLC
General & Plastic Surgery · 271d
Cleared Oct 18, 2019
BIAFINE Topical Cream
K190342
Bausch Health Americas Incorporated
General & Plastic Surgery · 246d