510(k) Report

Devices descending from K062212

85 later devices reach Silver Shield Antimicrobial Skin and Wound Gel, Model 3015-S through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152519MTR550 (Tentative) Antimicrobial Silver Wound GelMedical Technology Research, Inc.20160—
+1K130857Prontosan Wound Gel XB.Braun Medical, Inc.20133—
+1K090345Mendasil TWG Gel Antimicrobial Skin and Wound GelConseal International, Inc.20100—
+1K082333Asap Wound Dressing GelAmerican Biotech Labs20096—
+1K073019Silvermed Antimicrobial Silver HydrogelArgentis Biomedical Incorporated20081—
+1K073197Silver Antimicrobial Wound GelAdvanced Medical Solutions Limited20082—
+1K073547Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound GelAnacapa Technologies, Inc.200866—
+1K072378Prowick Antimicrobial Postoperative Wound Dressing, Shoulder and Knee, Models AR-1625…Arthrex, Inc.20071—
+2K223259coactiv+™ Antimicrobial Wound GelKane Biotech, Inc.20231—
+2K192527Rochal Antimicrobial Wound GelRochal Industries, LLC20202—
+2K163188Next Science Wound Gel (Rx)Next Science, LLC20171—
+2K160192Atteris Antimicrobial Skin & Wound CleanserRochal Industries, LLC20169—
+2K160095Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science Antimicrobial…Simple Science, LLC20163—
+2K150792Next Science Wound GelNext Science, LLC20152—
+2K150799Puracyn (R) Plus Duo-Care (TM) Antimicrobial Wound & Skin Hydrogel, Puracyn (R) Plus…Innovacyn, Inc.20159—
+2K141863Puricore Wound Hydrogel Spray DressingPuricore, Inc.201510—
+2K132891Hydrolyzed Collagen/AG Wound Gel with SilverThe Hymed Group Corp.20140—
+2K140483Asap Otc Wound Dressing GelAbl Medical, LLC20141—
+2K131176Ross RU Skin DiscontinuitiesBiotd S.A.20141—
+2K113693Nixall TM Wound and Skin CareSeriously Clean, Ltd.201215—
+2K113820Neutrophase Antimicrobial Wound CleanserNovabay Pharmaceuticals201215—
+2K111313Exsept Skin and Wound Cleanser with Antimicrobial PreservativeAlcavis Hdc, LLC20119—
+2K110458Silver Antimicrobial Wound GelAdvanced Medical Solutions Limited20111—
+2K101882Prontosan Antimicrobial Wound GelB.Braun Medical, Inc.201021—
+2K100918Vashe Wound Therapy System Model: 9000-0014Puricore, Inc.201031—
+2K093697Vashe Wound Therapy SolutionPuricore, Inc.201020—
+2K093155Vashe Wound Cleansing SystemPuricore, Inc.20100—
+2K093227Silverstream and DermaseptEnzysurge, Ltd.20091—
+2K092826Asap Antimicrobial Silver Wound Dressing GelAmerican Biotech Labs20092—
+2K090791Dakin's Antimicrobial Wound Cleanser, Model 0.0125% to 5%Century Pharmaceuticals, Inc.200910—
+2K090206Oculus Puracyn Antimicrobial Skin and Wound CleanserOculus Innovative Sciences, Inc.2009373
+2K082858Exsept WC Antimicrobial Skin and Wound CleanserAlcavis International, Inc.20090—
+2K083007ProwickArthrex, Inc.20090—
+3K254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLC20260—
+3K252028LUOFUCON® Antimicrobial Wound GelHuizhou Foryou Medical Co., Ltd.20260—
+3K252759revyve® Antimicrobial Skin and Wound CleanserKane Biotech, Inc.20260—
+3K243457Nixall Antimicrobial Solutions™ Skin & Wound HydrogelSeriously Clean, Ltd.20250—
+3K241809coactiv+™ Antimicrobial Wound GelKane Biotech, Inc.20240—
+3K212521Field Shield Wound DressingKericure, Inc.20240—
+3K223377BIASURGE Advanced Surgical SolutionRochal Technologies, LLC20230—
+3K210536Irrisept Antimicrobial Wound LavageIrrimax Corporation20216—
+3K200767SilverStream GelEnzysurge, Ltd.20200—
+3K190224Medline Burn and Wound Dressing (OTC)Medline Industries, Inc.20190—
+3K181074Simple Science Antimicrobial Facial and Eyelid CleanserSimple Science, LLC20182—
+3K173911Medline Burn and Wound DressingMedline Industries, Inc.20182—
+3K180305Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC)Aquilabs Us, LLC20180—
+3K171935Alevicyn SG Antimicrobial GelSonoma Pharmaceuticals, Inc.20171—
+3K172622Microcyn Antimicrobial Skin and Wound CleanserSonoma Pharmaceuticals20173—
+3K163430Prontosan Wound GelB.Braun Medical, Inc.20171—
+3K162017Ross Ru Wound Dressing GelBiotd S.A.20170—
+3K151168Nexodyn AOS Wound Care SolutionApr Applied Pharma Research SA20150—
+3K150985Medihoney Wound GelDerma Sciences, Inc.201501
+3K142592CleanSmart Wound CleanserSimple Science, LLC20154—
+3K141660Nawalution Skin and Wound CleanserNawa Heilmittel GmbH20142—
+3K141012Hydrocleanse Wound Care SolutionOculus Innovative Sciences20144—
+3K133542Puracyn Plus Skin and WoundInnovacyn, Inc.201414—
+3K131848Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ)Puricore, Inc.20148—
+3K131542Neutrophase (R) Skin and Wound Cleanser OtcNovabay Pharmaceuticals, Inc.20133—
+3K123072Vashe Wound Therapy SolutionPuricore, Inc.201325—
+3K110744Prontosan Wound Irrigation SolutionB.Braun Medical, Inc.20114—
+4K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbH20260—
+4K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLC20260—
+4K254191IWD-Gel™InnovaCorium, Inc.20260—
+4K252023MiraChlor Antimicrobial Wound SolutionLetus Corporation20260—
+4K250642LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.)Huizhou Foryou Medical Devices Co., Ltd.20250—
+4K243415Granudacyn® Wound Irrigation SolutionP.G.F. Industry Solutions GmbH20251—
+4K233399Microdacyn Wound Care SolutionSonoma Pharmaceuticals, Inc.20241—
+4K240552Irrisept Antimicrobial Wound LavageIrrimax Corporation20240—
+4K232080Puracyn® Plus Antimicrobial Irrigation SolutionInnovacyn, Inc.20241—
+4K231564Skin and Wound CleanserWinner Medical Co., Ltd.20230—
+4K220286ELECTROCYN somaV3Bio Sdn. Bhd20220—
+4K222804Irrisept Antimicrobial Wound LavageIrrimax Corporation20220—
+4K213616BD Surgiphor Antimicrobial Irrigation SystemBecton, Dickinson and Company20223—
+4K181428Clyra Wound Irrigation SolutionClyra Medical Technologies, Inc.20195—
+4K173896Microcyn Antimicrobial HydrogelSonoma Pharmaceuticals, Inc.20180—
+4K161034Microcyn Plus Wound Care SolutionOculus Innovative Sciences20163—
+5K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.20260—
+5K251757Puracyn® Plus Antimicrobial Irrigation SolutionInnovacyn, Inc.20260—
+5K213514Spectricept Skin and Wound CleanserSpectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc.20231—
+5K221504BD Surgiphor™ Antimicrobial Irrigation SystemBd20222—
+5K202071SURGIPHOR Wound Irrigation SystemOrthophor, LLC20204—
+5K172851Microcyn Plus Antimicrobial Wound Care SolutionSonoma Pharmaceuticals, Inc.201701
+6K253996BD Surgiphor™ Antimicrobial Irrigation System (910110)Becton, Dickinson and Company (BD)20260—
+6K253445BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)Bd20260—
+6K243875Spectricept Skin and Wound CleanserSpectrum Antimicrobials, Inc.20250—