510(k) Report

Devices descending from K023612

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150256Silverlon Burn Contact DressingsArgentum Medical20154—
+1K120181Lufucon Silver Alginate Dressing 50X50MM, Lufucon Silver Alginate Dressing 100X100MM…Huizhou Foryou Medical Devices Co., Ltd.20136—
+1K073213Therabond Antimicrobial Barrier SystemsChoice Therapeutics20085—
+1K063069Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC200773—
+1K063063Silvacide Skin & Wound Moisturizing SolutionMedical Molecular Therapuetics, LLC200714—
+1K050842Agcel Wound Dressing,Agcel Burn DressingModern Medical Equipment Mfg., Ltd.20060—
+1K050726Silverseal Silveraid with X-StaticNoble Fiber Technologies, Inc.20052—
+1K051445Milliken Silver Wound DressingsMilliken Chemical20053—
+1K050649Silverseal Contacting Wound Dressing with X-StaticNoble Fiber Technologies, Inc.20055—
+1K033587SilversealNoble Fiber Technologies20049—
+2K190343Silverlon Wound Contact, Burn Contact DressingsArgentum Medical, LLC20193—
+2K172554LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial Alginate DressingHuizhou Foryou Medical Devices Co., Ltd.20183—
+2K151185AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser (Rx) and AGX Wound Wash…Abl Medical, LLC20160—
+2K143335Roosin Silver Calcium Alginate Dressing (Prescription), Roosin Alginate Dressing with…Roosin Medical Devices Co., Ltd.20151—
+2K111313Exsept Skin and Wound Cleanser with Antimicrobial PreservativeAlcavis Hdc, LLC20119—
+2K103141Low Adherent Afm AG DressingsMilliken Healthcare Products, LLC20110—
+2K093188Afm Ultra AG DressingsMilliken & Co.20101—
+2K093227Silverstream and DermaseptEnzysurge, Ltd.20091—
+2K083133Silveri: Coflex Afd, Coflex Afd First Aid, Afd Pad Foam Dressing, Powerflex Afd Foam…Andover Healthcare, Inc.20093—
+2K082858Exsept WC Antimicrobial Skin and Wound CleanserAlcavis International, Inc.20090—
+2K083355Wound Wash Saline, 210 ML, Model B8552, Wound Wash Saline, 90 ML, Model B8553Blairex Laboratories, Inc.200813—
+2K073547Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound GelAnacapa Technologies, Inc.200866—
+2K072378Prowick Antimicrobial Postoperative Wound Dressing, Shoulder and Knee, Models AR-1625…Arthrex, Inc.20071—
+2K063190Silverseal Wound Packing Strips with X-StaticNoble Fiber Technologies, Inc.20070—
+3K212521Field Shield Wound DressingKericure, Inc.20240—
+3K223360LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam DressingHuizhou Foryou Medical Devices Co., Ltd.20241—
+3K223359LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam DressingHuizhou Foryou Medical Devices Co., Ltd.20230—
+3K230190Polyver Silver Alginate Dressing (Prescription and OTC)Roosin Medical Co., Ltd.20230—
+3K221218Silverlon Wound Contact, Burn Contact DressingsArgentum Medical, Inc.20221—
+3K202982Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC…Winner Medical Co., Ltd.20211—
+3K201016LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Antibacterial Alginate Wound…Huizhou Foryou Medical Devices Co., Ltd.20210—
+3K200767SilverStream GelEnzysurge, Ltd.20200—
+3K183662Saline Wound Wash, SteriCleanse (TM)Ascent Consumer Products, Inc.20190—
+3K163188Next Science Wound Gel (Rx)Next Science, LLC20171—
+3K160192Atteris Antimicrobial Skin & Wound CleanserRochal Industries, LLC20169—
+3K160095Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science Antimicrobial…Simple Science, LLC20163—
+3K150792Next Science Wound GelNext Science, LLC20152—
+3K150799Puracyn (R) Plus Duo-Care (TM) Antimicrobial Wound & Skin Hydrogel, Puracyn (R) Plus…Innovacyn, Inc.20159—
+3K141863Puricore Wound Hydrogel Spray DressingPuricore, Inc.201510—
+3K141603Ultra Silver DressingsMilliken Healthcare Products, LLC20140—
+3K131848Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ)Puricore, Inc.20148—
+3K123910Woundwash Saline SprayNeilmed Pharmaceuticals, Inc.20130—
+3K113693Nixall TM Wound and Skin CareSeriously Clean, Ltd.201215—
+3K113820Neutrophase Antimicrobial Wound CleanserNovabay Pharmaceuticals201215—
+3K101882Prontosan Antimicrobial Wound GelB.Braun Medical, Inc.201021—
+3K100918Vashe Wound Therapy System Model: 9000-0014Puricore, Inc.201031—
+3K093697Vashe Wound Therapy SolutionPuricore, Inc.201020—
+3K093155Vashe Wound Cleansing SystemPuricore, Inc.20100—
+3K090791Dakin's Antimicrobial Wound Cleanser, Model 0.0125% to 5%Century Pharmaceuticals, Inc.200910—
+3K090848Premier Sterile Saline Wound Wash, Models 210 ML, WWMPremier Brands of America, Inc.20091—
+3K090206Oculus Puracyn Antimicrobial Skin and Wound CleanserOculus Innovative Sciences, Inc.2009373
+3K083007ProwickArthrex, Inc.20090—
+4K254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLC20260—
+4K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLC20260—
+4K252028LUOFUCON® Antimicrobial Wound GelHuizhou Foryou Medical Co., Ltd.20260—
+4K252759revyve® Antimicrobial Skin and Wound CleanserKane Biotech, Inc.20260—
+4K243415Granudacyn® Wound Irrigation SolutionP.G.F. Industry Solutions GmbH20251—
+4K243457Nixall Antimicrobial Solutions™ Skin & Wound HydrogelSeriously Clean, Ltd.20250—
+4K242856LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+…Huizhou Foryou Medical Devices Co., Ltd.20240—
+4K241225Silverlon® Wound Contact, Burn Contact DressingArgentum Medical, LLC20240—
+4K223377BIASURGE Advanced Surgical SolutionRochal Technologies, LLC20230—
+4K220673Sterile Silver Alginate Wound DressingQingdao Bright Moon Biomedical Materials Co., Ltd.20230—
+4K210987IRRIGO Wound Wash Jet SystemInopro, Inc.20220—
+4K210536Irrisept Antimicrobial Wound LavageIrrimax Corporation20216—
+4K190224Medline Burn and Wound Dressing (OTC)Medline Industries, Inc.20190—
+4K181074Simple Science Antimicrobial Facial and Eyelid CleanserSimple Science, LLC20182—
+4K173911Medline Burn and Wound DressingMedline Industries, Inc.20182—
+4K180305Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC)Aquilabs Us, LLC20180—
+4K171935Alevicyn SG Antimicrobial GelSonoma Pharmaceuticals, Inc.20171—
+4K172622Microcyn Antimicrobial Skin and Wound CleanserSonoma Pharmaceuticals20173—
+4K163430Prontosan Wound GelB.Braun Medical, Inc.20171—
+4K161034Microcyn Plus Wound Care SolutionOculus Innovative Sciences20163—
+4K151168Nexodyn AOS Wound Care SolutionApr Applied Pharma Research SA20150—
+4K142592CleanSmart Wound CleanserSimple Science, LLC20154—
+4K141660Nawalution Skin and Wound CleanserNawa Heilmittel GmbH20142—
+4K141012Hydrocleanse Wound Care SolutionOculus Innovative Sciences20144—
+4K133542Puracyn Plus Skin and WoundInnovacyn, Inc.201414—
+4K131542Neutrophase (R) Skin and Wound Cleanser OtcNovabay Pharmaceuticals, Inc.20133—
+4K123072Vashe Wound Therapy SolutionPuricore, Inc.201325—
+4K110744Prontosan Wound Irrigation SolutionB.Braun Medical, Inc.20114—
+5K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbH20260—
+5K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.20260—
+5K254191IWD-Gel™InnovaCorium, Inc.20260—
+5K252023MiraChlor Antimicrobial Wound SolutionLetus Corporation20260—
+5K250642LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.)Huizhou Foryou Medical Devices Co., Ltd.20250—
+5K233399Microdacyn Wound Care SolutionSonoma Pharmaceuticals, Inc.20241—
+5K240552Irrisept Antimicrobial Wound LavageIrrimax Corporation20240—
+5K232080Puracyn® Plus Antimicrobial Irrigation SolutionInnovacyn, Inc.20241—
+5K231564Skin and Wound CleanserWinner Medical Co., Ltd.20230—
+5K213514Spectricept Skin and Wound CleanserSpectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc.20231—
+5K220286ELECTROCYN somaV3Bio Sdn. Bhd20220—
+5K222804Irrisept Antimicrobial Wound LavageIrrimax Corporation20220—
+5K213616BD Surgiphor Antimicrobial Irrigation SystemBecton, Dickinson and Company20223—
+5K181428Clyra Wound Irrigation SolutionClyra Medical Technologies, Inc.20195—
+5K173896Microcyn Antimicrobial HydrogelSonoma Pharmaceuticals, Inc.20180—
+5K172851Microcyn Plus Antimicrobial Wound Care SolutionSonoma Pharmaceuticals, Inc.201701
+6K251757Puracyn® Plus Antimicrobial Irrigation SolutionInnovacyn, Inc.20260—
+6K243875Spectricept Skin and Wound CleanserSpectrum Antimicrobials, Inc.20250—
+6K221504BD Surgiphor™ Antimicrobial Irrigation SystemBd20222—
+6K202071SURGIPHOR Wound Irrigation SystemOrthophor, LLC20204—