510(k) Report

Devices descending from K013814

68 later devices reach Absorbent Antimicrobial Wound Dressing through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111382CelverCellulose Concepts, LLC20120—
+1K080503Silver Alginate IV Antimicrobial Wound DressingAdvanced Medical Solutions Limited20080—
+1K081584Derma Sciences Otc Medihoney Dressings with Active Manuka HoneyDerma Sciences, Inc.200814—
+1K071442Suprasorb a +AGSpecialty Fibres and Materials, Ltd.200811
+1K070581Silver Alginate II Wound DressingAdvanced Medical Solutions Limited20073—
+1K063173Modification to Silver Alginate II Wound DressingAdvanced Medical Solutions Limited20063—
+1K033523Collagen-Orc Antimicrobial MatrixJohnson & Johnson Medical, Ltd.20044—
+1K041316Antimicrobial Alginate DressingAdvanced Medical Solutions, Ltd.200416—
+1K033869Contreet Foam Cavity Dressing with Silver, Model 9628 (2X4 in.)Coloplast Corp.200417—
+1K032463Curad Silver BandageBeiersdorf AG20042—
+1K032462Curad Silver Active Gel BandageBeiersdorf AG20040—
+1K024054Xylos Xcell Antimicrobial DressingXylos Corporation20037—
+2K230190Polyver Silver Alginate Dressing (Prescription and OTC)Roosin Medical Co., Ltd.20230—
+2K183208Suprasorb A + Ag “R”Speciality Fibres and Materials, Ltd.20190—
+2K123961Sentrex Biosponge MPDBionova Medical, Inc.20134—
+2K120181Lufucon Silver Alginate Dressing 50X50MM, Lufucon Silver Alginate Dressing 100X100MM…Huizhou Foryou Medical Devices Co., Ltd.20136—
+2K101114Advancis Activon TubeAdvancis Medical20110—
+2K101793Medihoney Gel Dressing with Active Manuka HoneyDerma Sciences, Inc.201124
+2K102659Manukahd, Manukahd Rope, Manukahd BorderManuka Medical Limited20103—
+2K100580Exsalt Wound DressingExciton Technologies, Inc.20100—
+2K093351Collawound ArtCollamatrix, Inc.20100—
+2K092689Manukapli Wound DressingManuka Medical Limited201010—
+2K100218Biatain Agfoam Dressings-Non-Adhesiv: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CMColoplast A/S201011—
+2K082910CVS Silver Bandages, Walgreens Silver Bandages, Xyz Silver BandagesAso, LLC20090—
+2K090453Silver Alginate 11 Wound DressingAdvanced Medical Solutions Limited200903
+2K080949Keratec Wound DressingsKeratec Limited20093—
+2K081363Non-Adherent Antimicrobial Alginate Dressing, Silvercel Non-Adherent Antimicrobial…Advanced Medical Solutions Limited20080—
+2K053590Silverlon CA (Calcium Alginate)Argentum Medical, LLC20061—
+2K050032Euromed Sureskin Iii with Silver Wound DressingsEuromed, Inc.20062—
+2K051647Fortaderm Antimicrobial Wound DressingOrganogenesis, Inc.20053—
+3K254246LT Antibacterial Foam with Silver DressingZhejiang Longterm Medical Technology Co., Ltd.20260—
+3K251582Redermax Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.20261—
+3K210949Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc.20223—
+3K192478LT Antibacterial Alginate with Silver DressingZhejiang Longterm Medical Technology Co., Ltd.20200—
+3K191819Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing…Winner Medical Co., Ltd.20201—
+3K191536Biatain Silicone AgColoplast A/S20200—
+3K182010ProgenaMatrixCell Constructs I, LLC201901
+3K172554LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial Alginate DressingHuizhou Foryou Medical Devices Co., Ltd.20183—
+3K162759KeraStat (R) GelKeranetics, LLC20171—
+3K150676L-Mesitran Dressing Family II- Soft and TulleTheo Manufacturing BV20150—
+3K151186Stay Fresh Hydrocolloid dressingSarasota Medical Products, Inc.20150—
+3K150985Medihoney Wound GelDerma Sciences, Inc.201501
+3K143335Roosin Silver Calcium Alginate Dressing (Prescription), Roosin Alginate Dressing with…Roosin Medical Devices Co., Ltd.20151—
+3K140954Luofucon Silver PU Antibacterial Foam DressingHuizhou Foryou Medical Devices Co., Ltd.20155—
+3K121227Manuka FillLinks Medical Products, Inc.20124—
+3K120828Biatain Silicone AG Foam Dressing - Adhesive: 3X3 Inches, 4X4 Inches, & 5X5 InchesColoplast A/S20122—
+3K110042ManukatexManuka Medical Limited20112—
+3K081274Sureskin Silver BandagesEuromed, Inc.20081—
+4K261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.20260—
+4K223359LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam DressingHuizhou Foryou Medical Devices Co., Ltd.20230—
+4K231937Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc.20232—
+4K221754Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone Ag Foam…Winner Medical Co., Ltd.20230—
+4K202982Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC…Winner Medical Co., Ltd.20211—
+4K201016LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Antibacterial Alginate Wound…Huizhou Foryou Medical Devices Co., Ltd.20210—
+4K192386KeraStat CreamKeranetics20200—
+4K160022LUOFUCON Silicone Ag foam dressingHuizhou Foryou Medical Devices Co., Ltd.20163—
+4K131796Manuka Fill Wound DressingLinks Medical Products, Inc.201431
+4K120976Manuka IGLinks Medical Products, Inc.20121—
+5K243181Foundation Dermal Regeneration Scaffold Plus (DRS+) SoloBionova Medical, Inc.20240—
+5K240298Foundation Dermal Regeneration Scaffold Plus (DRS+) DuoBionova Medical, Inc.20241—
+5K220673Sterile Silver Alginate Wound DressingQingdao Bright Moon Biomedical Materials Co., Ltd.20230—
+5K173911Medline Burn and Wound DressingMedline Industries, Inc.20182—
+5K170077LUOFUCON Silicone Ag Foam Dressing with BorderHuizhou Foryou Medical Devices Co., Ltd.20172—
+5K133934Manuka Foam HC, Manuka Foam HC (with Acrylic Adhesive Border), Manuka Foam HC (with…Links Medical Products, Inc.20140—
+6K254191IWD-Gel™InnovaCorium, Inc.20260—
+6K223360LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam DressingHuizhou Foryou Medical Devices Co., Ltd.20241—
+6K190224Medline Burn and Wound Dressing (OTC)Medline Industries, Inc.20190—
+7K242856LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+…Huizhou Foryou Medical Devices Co., Ltd.20240—