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
97–120 of 705
Cleared Oct 11, 2019
Protego Antimicrobial Wound Dressing
K183681
Global Health Solutions (Dba Turn Therapeutics)
General & Plastic Surgery · 287d
Cleared Sep 20, 2019
Clyra Wound Irrigation Solution
K181428
Clyra Medical Technologies, Inc.
General & Plastic Surgery · 476d
Cleared Sep 13, 2019
Roosin Xeroform Petrolatum Dressing
K181478
Roosin Medical Co., Ltd.
General & Plastic Surgery · 465d
Cleared Sep 12, 2019
Saline Wound Wash, SteriCleanse(TM)
K183662
Ascent Consumer Products, Inc.
General & Plastic Surgery · 259d
Cleared Aug 15, 2019
Suprasorb A + Ag “R”
K183208
Speciality Fibres and Materials, Ltd.
General & Plastic Surgery · 269d
Cleared Jul 25, 2019
Silicone PHMB Foam Wound Dressing
K190819
Advanced Medical Solutions, Ltd.
General & Plastic Surgery · 115d
Cleared Jul 18, 2019
Silverlon Wound Contact, Burn Contact Dressings
K190343
Argentum Medical, LLC
General & Plastic Surgery · 154d
Cleared May 31, 2019
Apis
K182725
Sweetbio, Inc.
General & Plastic Surgery · 245d
Cleared May 29, 2019
Silver High Performance Dressing
K183645
Advanced Medical Solutions, Ltd.
General & Plastic Surgery · 154d
Cleared Mar 08, 2019
Medline Burn and Wound Dressing (OTC)
K190224
Medline Industries, Inc.
General & Plastic Surgery · 31d
Cleared Feb 14, 2019
Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing, Antimicrobial non-woven sponge dressing
K181315
Winner Medical Co., Ltd.
General & Plastic Surgery · 272d
Cleared Jan 14, 2019
Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon Burn Pad Dressing)
K180570
Argentum Medical, LLC
General & Plastic Surgery · 315d
Cleared Dec 14, 2018
AC5 Topical Gel
K182681
Arch Therapeutics, Inc.
General & Plastic Surgery · 79d
Cleared Dec 10, 2018
Procellera Composite Antibacterial Wound Dressing
K180533
Vomaris Wound Care, Inc.
General & Plastic Surgery · 285d
Cleared Dec 06, 2018
KerraContact Ag Perf Advanced Perforated Silver Wound Dressing
K182680
Exciton Technologies, Inc.
General & Plastic Surgery · 71d
Cleared Nov 23, 2018
MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs)
K180643
Medcu Technologies , Ltd.
General & Plastic Surgery · 256d
Cleared Sep 07, 2018
AMSure Sterile Water, and Sterile Normal Saline for Wound Flush
K181423
Amsino International, Inc.
General & Plastic Surgery · 99d
Cleared Aug 17, 2018
Simple Science Antimicrobial Facial and Eyelid Cleanser
K181074
Simple Science, LLC
General & Plastic Surgery · 115d
Cleared Aug 13, 2018
BIAFINE
K173549
Valeant Pharmaceuticals
General & Plastic Surgery · 270d
Cleared Aug 09, 2018
Titan Ag 200
K173844
Specialty Fibres and Materials, Ltd.
General & Plastic Surgery · 233d
Cleared Aug 07, 2018
Surgical Silver Post Operative Dressing
K180634
Advanced Medical Solutions, Ltd.
General & Plastic Surgery · 148d
Cleared Aug 03, 2018
PHMB Foam Wound Dressing
K181197
Advanced Medical Solutions, Ltd.
General & Plastic Surgery · 88d
Cleared Jul 20, 2018
AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber
K173675
Convatec Limited
General & Plastic Surgery · 232d
Cleared Jul 19, 2018
Medline Burn and Wound Dressing
K173911
Medline Industries, Inc.
General & Plastic Surgery · 209d