510(k) Report

Devices descending from K914579

162 later devices reach Silver Foam Wound Dressing through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K955453Acticoat Silver Coated DressingWestaim Technologies, Inc.1996161—
+2K063805Silcryst Silver Antimicrobial Wound Cream, Model a-00901Nucryst Pharmaceuticals, Inc.20070—
+2K060237CMB Antimicrobial DressingSilverleaf Medical Products, Inc.20064—
+2K050086Brennen Medical Silver Glucan Wound DressingBrennen Medical, Inc.20060—
+2K0532563M Tegaderm Silver (AG) Mesh3M Company20051—
+2K033587SilversealNoble Fiber Technologies20049—
+2K983833Acticoat Composite Wound Dressing, Acticoat Composite Wound Dressing-AdhesiveWestaim Biomedical, Inc.19988—
+2K981299Silverlon Contact Wound DressingArgentum International, LLC1998149—
+3K180533Procellera Composite Antibacterial Wound DressingVomaris Wound Care, Inc.20180—
+3K160783ProcelleraVomaris Innovations, Inc.20161—
+3K153756Microlyte AgImbed Biosciences, Inc.20161—
+3K152544Agem Ag Mesh Dressing with SilverShenzhen Yuanxing Nano-Pharma Co., Ltd.20160—
+3K141033Silverlon Antimicrobial Wound Contact Negative Pressure Dressings, Silverlon Easy AG…Argentum Medical, LLC20140—
+3K133137Cisnap Closed Incision SystemSpiracur, Inc.20140—
+3K130350ProcelleraVomaris Innovations, Inc.20132—
+3K083113Acticoat Flex 7 DressingSmith & Nephew, Inc.200922—
+3K081977Prosit Wound Treatment DeviceSilverleaf Medical Products, Inc.20083—
+3K073213Therabond Antimicrobial Barrier SystemsChoice Therapeutics20085—
+3K063190Silverseal Wound Packing Strips with X-StaticNoble Fiber Technologies, Inc.20070—
+3K984204Silverlon Direct Pressure Wound Closure StripArgentum International, LLC20070—
+3K050726Silverseal Silveraid with X-StaticNoble Fiber Technologies, Inc.20052—
+3K050649Silverseal Contacting Wound Dressing with X-StaticNoble Fiber Technologies, Inc.20055—
+3K040518Select Fabricators, Inc., Agmed Tex Wound DressingSelect Fabricators, Inc.20041—
+3K032463Curad Silver BandageBeiersdorf AG20042—
+3K032462Curad Silver Active Gel BandageBeiersdorf AG20040—
+3K023612Silverlon Contact Wound DressingArgentum International, LLC2003102—
+3K023609Silverlon Adhesive StripArgentum International, LLC200321—
+3K992221Acticoat Primary Antimicrobial DressingWestaim Biomedical, Inc.20003—
+3K984210Silverlon Wound Packing StripsArgentum International, LLC199925—
+3K984208Silverlon Island Dressing, Silverlon Island PadArgentum International, LLC199914—
+4K211943Microlyte Ag/LidocaineImbed Biosciences20240—
+4K153723ACTICOAT Surgical DressingSmith & Nephew Medical Limited20160—
+4K150256Silverlon Burn Contact DressingsArgentum Medical20154—
+4K122817Silverlon Island Wound DressingArgentum Medical, LLC201413—
+4K123961Sentrex Biosponge MPDBionova Medical, Inc.20134—
+4K120181Lufucon Silver Alginate Dressing 50X50MM, Lufucon Silver Alginate Dressing 100X100MM…Huizhou Foryou Medical Devices Co., Ltd.20136—
+4K103793Durafiber AGSmith & Nephew, Inc.20111—
+4K100580Exsalt Wound DressingExciton Technologies, Inc.20100—
+4K083133Silveri: Coflex Afd, Coflex Afd First Aid, Afd Pad Foam Dressing, Powerflex Afd Foam…Andover Healthcare, Inc.20093—
+4K082910CVS Silver Bandages, Walgreens Silver Bandages, Xyz Silver BandagesAso, LLC20090—
+4K082333Asap Wound Dressing GelAmerican Biotech Labs20096—
+4K072378Prowick Antimicrobial Postoperative Wound Dressing, Shoulder and Knee, Models AR-1625…Arthrex, Inc.20071—
+4K063069Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC200773—
+4K063063Silvacide Skin & Wound Moisturizing SolutionMedical Molecular Therapuetics, LLC200714—
+4K050842Agcel Wound Dressing,Agcel Burn DressingModern Medical Equipment Mfg., Ltd.20060—
+4K051445Milliken Silver Wound DressingsMilliken Chemical20053—
+4K033869Contreet Foam Cavity Dressing with Silver, Model 9628 (2X4 in.)Coloplast Corp.200417—
+4K011941Excilon Amd Antimicrobial Sponge Model #7088The Kendall Company20011—
+5K223360LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam DressingHuizhou Foryou Medical Devices Co., Ltd.20241—
+5K223359LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam DressingHuizhou Foryou Medical Devices Co., Ltd.20230—
+5K210949Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc.20223—
+5K190343Silverlon Wound Contact, Burn Contact DressingsArgentum Medical, LLC20193—
+5K172554LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial Alginate DressingHuizhou Foryou Medical Devices Co., Ltd.20183—
+5K161289DURAFIBER AgSmith & Nephew Medical Limited20160—
+5K151185AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser (Rx) and AGX Wound Wash…Abl Medical, LLC20160—
+5K143335Roosin Silver Calcium Alginate Dressing (Prescription), Roosin Alginate Dressing with…Roosin Medical Devices Co., Ltd.20151—
+5K143001Silverlon Island Wound Dressing, Silverlon Wound Pad DressingArgentum Medical20145—
+5K141573Silverlon Island Wound DressingArgentum Medical20140—
+5K140483Asap Otc Wound Dressing GelAbl Medical, LLC20141—
+5K131176Ross RU Skin DiscontinuitiesBiotd S.A.20141—
+5K111313Exsept Skin and Wound Cleanser with Antimicrobial PreservativeAlcavis Hdc, LLC20119—
+5K103141Low Adherent Afm AG DressingsMilliken Healthcare Products, LLC20110—
+5K100218Biatain Agfoam Dressings-Non-Adhesiv: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CMColoplast A/S201011—
+5K093188Afm Ultra AG DressingsMilliken & Co.20101—
+5K093227Silverstream and DermaseptEnzysurge, Ltd.20091—
+5K092826Asap Antimicrobial Silver Wound Dressing GelAmerican Biotech Labs20092—
+5K082858Exsept WC Antimicrobial Skin and Wound CleanserAlcavis International, Inc.20090—
+5K083007ProwickArthrex, Inc.20090—
+5K083355Wound Wash Saline, 210 ML, Model B8552, Wound Wash Saline, 90 ML, Model B8553Blairex Laboratories, Inc.200813—
+5K073547Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound GelAnacapa Technologies, Inc.200866—
+5K070685Kendall Antimicrobial Drain Dressing for Otc Use, Model 6662Tyco Healthcare20070—
+6K254246LT Antibacterial Foam with Silver DressingZhejiang Longterm Medical Technology Co., Ltd.20260—
+6K242856LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+…Huizhou Foryou Medical Devices Co., Ltd.20240—
+6K212521Field Shield Wound DressingKericure, Inc.20240—
+6K230190Polyver Silver Alginate Dressing (Prescription and OTC)Roosin Medical Co., Ltd.20230—
+6K231937Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc.20232—
+6K221218Silverlon Wound Contact, Burn Contact DressingsArgentum Medical, Inc.20221—
+6K202982Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC…Winner Medical Co., Ltd.20211—
+6K201016LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Antibacterial Alginate Wound…Huizhou Foryou Medical Devices Co., Ltd.20210—
+6K200767SilverStream GelEnzysurge, Ltd.20200—
+6K191819Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing…Winner Medical Co., Ltd.20201—
+6K191536Biatain Silicone AgColoplast A/S20200—
+6K183662Saline Wound Wash, SteriCleanse (TM)Ascent Consumer Products, Inc.20190—
+6K180570Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon…Argentum Medical, LLC20191—
+6K180643MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs)Medcu Technologies, Ltd.20181—
+6K162017Ross Ru Wound Dressing GelBiotd S.A.20170—
+6K163188Next Science Wound Gel (Rx)Next Science, LLC20171—
+6K160192Atteris Antimicrobial Skin & Wound CleanserRochal Industries, LLC20169—
+6K160095Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science Antimicrobial…Simple Science, LLC20163—
+6K150792Next Science Wound GelNext Science, LLC20152—
+6K150799Puracyn (R) Plus Duo-Care (TM) Antimicrobial Wound & Skin Hydrogel, Puracyn (R) Plus…Innovacyn, Inc.20159—
+6K150985Medihoney Wound GelDerma Sciences, Inc.201501
+6K141863Puricore Wound Hydrogel Spray DressingPuricore, Inc.201510—
+6K140954Luofucon Silver PU Antibacterial Foam DressingHuizhou Foryou Medical Devices Co., Ltd.20155—
+6K141603Ultra Silver DressingsMilliken Healthcare Products, LLC20140—
+6K131848Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ)Puricore, Inc.20148—
+6K123910Woundwash Saline SprayNeilmed Pharmaceuticals, Inc.20130—
+6K113693Nixall TM Wound and Skin CareSeriously Clean, Ltd.201215—
+6K113820Neutrophase Antimicrobial Wound CleanserNovabay Pharmaceuticals201215—
+6K120828Biatain Silicone AG Foam Dressing - Adhesive: 3X3 Inches, 4X4 Inches, & 5X5 InchesColoplast A/S20122—