510(k) Report

Devices descending from K981299

149 later devices reach Silverlon Contact Wound Dressing through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153756Microlyte AgImbed Biosciences, Inc.20161—
+1K141033Silverlon Antimicrobial Wound Contact Negative Pressure Dressings, Silverlon Easy AG…Argentum Medical, LLC20140—
+1K133137Cisnap Closed Incision SystemSpiracur, Inc.20140—
+1K083113Acticoat Flex 7 DressingSmith & Nephew, Inc.200922—
+1K073213Therabond Antimicrobial Barrier SystemsChoice Therapeutics20085—
+1K984204Silverlon Direct Pressure Wound Closure StripArgentum International, LLC20070—
+1K050086Brennen Medical Silver Glucan Wound DressingBrennen Medical, Inc.20060—
+1K040518Select Fabricators, Inc., Agmed Tex Wound DressingSelect Fabricators, Inc.20041—
+1K033587SilversealNoble Fiber Technologies20049—
+1K023612Silverlon Contact Wound DressingArgentum International, LLC2003102—
+1K023609Silverlon Adhesive StripArgentum International, LLC200321—
+1K984210Silverlon Wound Packing StripsArgentum International, LLC199925—
+1K984208Silverlon Island Dressing, Silverlon Island PadArgentum International, LLC199914—
+2K211943Microlyte Ag/LidocaineImbed Biosciences20240—
+2K153723ACTICOAT Surgical DressingSmith & Nephew Medical Limited20160—
+2K150256Silverlon Burn Contact DressingsArgentum Medical20154—
+2K122817Silverlon Island Wound DressingArgentum Medical, LLC201413—
+2K123961Sentrex Biosponge MPDBionova Medical, Inc.20134—
+2K120181Lufucon Silver Alginate Dressing 50X50MM, Lufucon Silver Alginate Dressing 100X100MM…Huizhou Foryou Medical Devices Co., Ltd.20136—
+2K103793Durafiber AGSmith & Nephew, Inc.20111—
+2K100580Exsalt Wound DressingExciton Technologies, Inc.20100—
+2K082333Asap Wound Dressing GelAmerican Biotech Labs20096—
+2K063190Silverseal Wound Packing Strips with X-StaticNoble Fiber Technologies, Inc.20070—
+2K063069Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC200773—
+2K063063Silvacide Skin & Wound Moisturizing SolutionMedical Molecular Therapuetics, LLC200714—
+2K050842Agcel Wound Dressing,Agcel Burn DressingModern Medical Equipment Mfg., Ltd.20060—
+2K050726Silverseal Silveraid with X-StaticNoble Fiber Technologies, Inc.20052—
+2K051445Milliken Silver Wound DressingsMilliken Chemical20053—
+2K050649Silverseal Contacting Wound Dressing with X-StaticNoble Fiber Technologies, Inc.20055—
+2K033869Contreet Foam Cavity Dressing with Silver, Model 9628 (2X4 in.)Coloplast Corp.200417—
+2K032463Curad Silver BandageBeiersdorf AG20042—
+2K032462Curad Silver Active Gel BandageBeiersdorf AG20040—
+3K210949Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc.20223—
+3K190343Silverlon Wound Contact, Burn Contact DressingsArgentum Medical, LLC20193—
+3K172554LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial Alginate DressingHuizhou Foryou Medical Devices Co., Ltd.20183—
+3K161289DURAFIBER AgSmith & Nephew Medical Limited20160—
+3K151185AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser (Rx) and AGX Wound Wash…Abl Medical, LLC20160—
+3K143335Roosin Silver Calcium Alginate Dressing (Prescription), Roosin Alginate Dressing with…Roosin Medical Devices Co., Ltd.20151—
+3K143001Silverlon Island Wound Dressing, Silverlon Wound Pad DressingArgentum Medical20145—
+3K141573Silverlon Island Wound DressingArgentum Medical20140—
+3K140483Asap Otc Wound Dressing GelAbl Medical, LLC20141—
+3K131176Ross RU Skin DiscontinuitiesBiotd S.A.20141—
+3K111313Exsept Skin and Wound Cleanser with Antimicrobial PreservativeAlcavis Hdc, LLC20119—
+3K103141Low Adherent Afm AG DressingsMilliken Healthcare Products, LLC20110—
+3K100218Biatain Agfoam Dressings-Non-Adhesiv: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CMColoplast A/S201011—
+3K093188Afm Ultra AG DressingsMilliken & Co.20101—
+3K093227Silverstream and DermaseptEnzysurge, Ltd.20091—
+3K092826Asap Antimicrobial Silver Wound Dressing GelAmerican Biotech Labs20092—
+3K083133Silveri: Coflex Afd, Coflex Afd First Aid, Afd Pad Foam Dressing, Powerflex Afd Foam…Andover Healthcare, Inc.20093—
+3K082910CVS Silver Bandages, Walgreens Silver Bandages, Xyz Silver BandagesAso, LLC20090—
+3K082858Exsept WC Antimicrobial Skin and Wound CleanserAlcavis International, Inc.20090—
+3K083355Wound Wash Saline, 210 ML, Model B8552, Wound Wash Saline, 90 ML, Model B8553Blairex Laboratories, Inc.200813—
+3K073547Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound GelAnacapa Technologies, Inc.200866—
+3K072378Prowick Antimicrobial Postoperative Wound Dressing, Shoulder and Knee, Models AR-1625…Arthrex, Inc.20071—
+4K254246LT Antibacterial Foam with Silver DressingZhejiang Longterm Medical Technology Co., Ltd.20260—
+4K212521Field Shield Wound DressingKericure, Inc.20240—
+4K223360LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam DressingHuizhou Foryou Medical Devices Co., Ltd.20241—
+4K223359LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam DressingHuizhou Foryou Medical Devices Co., Ltd.20230—
+4K230190Polyver Silver Alginate Dressing (Prescription and OTC)Roosin Medical Co., Ltd.20230—
+4K231937Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc.20232—
+4K221218Silverlon Wound Contact, Burn Contact DressingsArgentum Medical, Inc.20221—
+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—
+4K200767SilverStream GelEnzysurge, Ltd.20200—
+4K191819Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing…Winner Medical Co., Ltd.20201—
+4K191536Biatain Silicone AgColoplast A/S20200—
+4K183662Saline Wound Wash, SteriCleanse (TM)Ascent Consumer Products, Inc.20190—
+4K180570Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon…Argentum Medical, LLC20191—
+4K180533Procellera Composite Antibacterial Wound DressingVomaris Wound Care, Inc.20180—
+4K180643MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs)Medcu Technologies, Ltd.20181—
+4K162017Ross Ru Wound Dressing GelBiotd S.A.20170—
+4K163188Next Science Wound Gel (Rx)Next Science, LLC20171—
+4K160192Atteris Antimicrobial Skin & Wound CleanserRochal Industries, LLC20169—
+4K160095Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science Antimicrobial…Simple Science, LLC20163—
+4K150792Next Science Wound GelNext Science, LLC20152—
+4K150799Puracyn (R) Plus Duo-Care (TM) Antimicrobial Wound & Skin Hydrogel, Puracyn (R) Plus…Innovacyn, Inc.20159—
+4K150985Medihoney Wound GelDerma Sciences, Inc.201501
+4K141863Puricore Wound Hydrogel Spray DressingPuricore, Inc.201510—
+4K140954Luofucon Silver PU Antibacterial Foam DressingHuizhou Foryou Medical Devices Co., Ltd.20155—
+4K141603Ultra Silver DressingsMilliken Healthcare Products, LLC20140—
+4K131848Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ)Puricore, Inc.20148—
+4K123910Woundwash Saline SprayNeilmed Pharmaceuticals, Inc.20130—
+4K113693Nixall TM Wound and Skin CareSeriously Clean, Ltd.201215—
+4K113820Neutrophase Antimicrobial Wound CleanserNovabay Pharmaceuticals201215—
+4K120828Biatain Silicone AG Foam Dressing - Adhesive: 3X3 Inches, 4X4 Inches, & 5X5 InchesColoplast A/S20122—
+4K101882Prontosan Antimicrobial Wound GelB.Braun Medical, Inc.201021—
+4K100918Vashe Wound Therapy System Model: 9000-0014Puricore, Inc.201031—
+4K093697Vashe Wound Therapy SolutionPuricore, Inc.201020—
+4K093155Vashe Wound Cleansing SystemPuricore, Inc.20100—
+4K090791Dakin's Antimicrobial Wound Cleanser, Model 0.0125% to 5%Century Pharmaceuticals, Inc.200910—
+4K090848Premier Sterile Saline Wound Wash, Models 210 ML, WWMPremier Brands of America, Inc.20091—
+4K090206Oculus Puracyn Antimicrobial Skin and Wound CleanserOculus Innovative Sciences, Inc.2009373
+4K083007ProwickArthrex, Inc.20090—
+5K254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLC20260—
+5K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLC20260—
+5K252028LUOFUCON® Antimicrobial Wound GelHuizhou Foryou Medical Co., Ltd.20260—
+5K252759revyve® Antimicrobial Skin and Wound CleanserKane Biotech, Inc.20260—
+5K243415Granudacyn® Wound Irrigation SolutionP.G.F. Industry Solutions GmbH20251—
+5K243457Nixall Antimicrobial Solutions™ Skin & Wound HydrogelSeriously Clean, Ltd.20250—
+5K242856LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+…Huizhou Foryou Medical Devices Co., Ltd.20240—