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 Winner Medical Co., Ltd..

707
Total
707
Cleared
187d
Avg days
1978
Since
707 devices
169–192 of 707
Cleared Aug 19, 2016
Microcyn Plus Wound Care Solution
K161034
Oculus Innovative Sciences
General & Plastic Surgery · 128d
Cleared Aug 17, 2016
LUOFUCON Silicone Ag foam dressing
K160022
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery · 225d
Cleared Aug 08, 2016
PermeaDerm B, PermeaDerm CW, and PermeaDerm Glove
K153678
Permeaderm, Inc.
General & Plastic Surgery · 231d
Cleared Aug 04, 2016
Microlyte Ag
K153756
Imbed Biosciences, Inc.
General & Plastic Surgery · 218d
Cleared Aug 03, 2016
DURAFIBER Ag
K161289
Smith & Nephew Medical Limited
General & Plastic Surgery · 86d
Cleared Jul 28, 2016
Atteris Antimicrobial Skin & Wound Cleanser
K160192
Rochal Industries, LLC
General & Plastic Surgery · 183d
Cleared Jul 21, 2016
Dakin's Skin and Wound Cleanser
K150208
Century Pharmaceuticals, Inc.
General & Plastic Surgery · 538d
Cleared Jul 01, 2016
Sorbact Foam Gentle Border, Sorbact Superabsorbent
K153674
Abigo Medical AB
General & Plastic Surgery · 193d
Cleared Jun 10, 2016
Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science Antimicrobial Wound & Skin Cleanser 8oz, Simple Science Antimicrobial Wound & Skin Cleanser 16oz, Simple Science Antimicrobial Wound & Skin Cleanser 23oz
K160095
Simple Science, LLC
General & Plastic Surgery · 143d
Cleared Jun 02, 2016
MTR550 (Tentative) Antimicrobial Silver Wound Gel
K152519
Medical Technology Research, Inc.
General & Plastic Surgery · 273d
Cleared May 23, 2016
Agem Ag Mesh Dressing with Silver
K152544
Shenzhen Yuanxing Nano-Pharma Co., Ltd.
General & Plastic Surgery · 262d
Cleared Apr 21, 2016
Dash-Topic Plus Cream
K150914
Founders Science Group, LLC
General & Plastic Surgery · 381d
Cleared Apr 19, 2016
Microcyn Plus Skin and Wound Hydrogel
K153648
Oculus Innovative Sciences
General & Plastic Surgery · 120d
Cleared Apr 14, 2016
Nutraseb Facial Cream
K143605
Isdin Corp.
General & Plastic Surgery · 482d
Cleared Feb 05, 2016
AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser (Rx) and AGX Wound Wash Skin and Wound Cleanser (OTC)
K151185
Abl Medical, LLC
General & Plastic Surgery · 277d
Cleared Jan 21, 2016
AQUACEL Ag Surgical SP Dressing
K152926
Convatec Limited
General & Plastic Surgery · 108d
Cleared Dec 23, 2015
L-Mesitran Dressing Family II- Soft and Tulle
K150676
Theo Manufacturing BV
General & Plastic Surgery · 282d
Cleared Dec 22, 2015
Nexodyn AOS Wound Care Solution
K151168
Apr Applied Pharma Research SA
General & Plastic Surgery · 235d
Cleared Dec 17, 2015
Next Science Wound Gel
K150792
Next Science, LLC
General & Plastic Surgery · 267d
Cleared Dec 15, 2015
Alevicyn SG Antipruritic Gel
K152945
Oculus Innovative Sciences
General & Plastic Surgery · 70d
Cleared Nov 27, 2015
Stay Fresh Hydrocolloid dressing
K151186
Sarasota Medical Products, Inc.
General & Plastic Surgery · 207d
Cleared Nov 23, 2015
Ceramax Skin Barrier Cream
K152055
Oculus Innovative Sciences
General & Plastic Surgery · 122d
Cleared Nov 19, 2015
Puracyn(R) Plus Duo-Care(TM) Antimicrobial Wound & Skin Hydrogel, Puracyn(R) Plus Antimicrobial Hydrogel Professional Formula
K150799
Innovacyn, Inc.
General & Plastic Surgery · 238d
Cleared Nov 19, 2015
Medihoney Wound Gel
K150985
Derma Sciences, Inc.
General & Plastic Surgery · 219d