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
145–168 of 707
Cleared Jul 25, 2017
PHMB Antimicrobial Foam Wound Dressing
K163062
Advanced Medical Solutions, Ltd.
General & Plastic Surgery · 265d
Cleared Jul 17, 2017
BD ChloraShield IV Dressing with CHG Antimicrobial
K170407
Avery Dennison Belgie Bvba
General & Plastic Surgery · 157d
Cleared Jun 23, 2017
Cerdak Basic
K153138
Bu Polysciences Equipment & Trading, LLC
General & Plastic Surgery · 602d
Cleared Jun 23, 2017
Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline
K170270
Ls Scientific Inc. D.B.A. Kse Scientific
General & Plastic Surgery · 147d
Cleared May 23, 2017
Prontosan Wound Gel
K163430
B.Braun Medical, Inc.
General & Plastic Surgery · 167d
Cleared Apr 20, 2017
Ross Ru Wound Dressing Gel
K162017
Biotd S.A.
General & Plastic Surgery · 273d
Cleared Mar 30, 2017
LUOFUCON Silicone Ag Foam Dressing with Border
K170077
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery · 80d
Cleared Mar 29, 2017
ReliaTect Post-Op Dressing with CHG (8cm x 15cm), ReliaTect Post-Op Dressing with CHG (10cm x 25cm)
K163529
Avery Dennison Corporation
General & Plastic Surgery · 103d
Cleared Mar 23, 2017
LOYON
K162217
Oculus Innovative Sciences
General & Plastic Surgery · 227d
Cleared Mar 06, 2017
Next Science Wound Gel (Rx)
K163188
Next Science, LLC
General & Plastic Surgery · 112d
Cleared Mar 03, 2017
Curasite
K161991
Izun Pharmaceuticals
General & Plastic Surgery · 227d
Cleared Feb 13, 2017
KerraCel Ag Gelling Fiber Silver Dressing
K162508
Exciton Technologies, Inc.
General & Plastic Surgery · 158d
Cleared Dec 06, 2016
Talymed Suspension
K160695
Marine Polymer Technologies, Inc.
General & Plastic Surgery · 267d
Cleared Nov 23, 2016
PolyPlex Wound Dressing
K160872
Global Health Solutions, LLC
General & Plastic Surgery · 238d
Cleared Nov 10, 2016
Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mL
K161623
B.Braun Medical, Inc.
General & Plastic Surgery · 150d
Cleared Oct 28, 2016
Xonrid Gel
K152533
Helsinn Healthcare SA
General & Plastic Surgery · 421d
Cleared Oct 03, 2016
Dynarex Xeroform Petrolatum Dressing
K152970
Dynarex Corporation
General & Plastic Surgery · 361d
Cleared Sep 30, 2016
Atteris Antimicrobial Skin Protectant
K161212
Rochal Industries, LLC
General & Plastic Surgery · 155d
Cleared Sep 22, 2016
DONASORB SILVER WOUND DRESSING
K153565
Virchow Biotech Pvt, Ltd.
General & Plastic Surgery · 283d
Cleared Sep 14, 2016
ACTICOAT Surgical Dressing
K153723
Smith & Nephew Medical Limited
General & Plastic Surgery · 261d
Cleared Sep 14, 2016
Anexa Wound Flush, Sterile Water & Sterile Normal Saline
K161658
Anexa Biomedical, Inc.
General & Plastic Surgery · 90d
Cleared Sep 07, 2016
Procellera
K160783
Vomaris Innovations, Inc.
General & Plastic Surgery · 169d
Cleared Aug 29, 2016
USP Sterile Water, 120 mL cup, USP Sterile Normal Saline (0.9% sodium chloride), 120 mL cup, USP Sterile Water, 100 mL,250 mL and 500 mL bottles, USP Sterile Normal Saline (0.9% sodium chloride), 100 mL, 250 mL and 500 mL bottles
K161311
Strukmyer Medical, LLC
General & Plastic Surgery · 111d
Cleared Aug 25, 2016
Exufiber Ag+
K160379
Molnlycke Health Care Us, LLC
General & Plastic Surgery · 197d