510(k) Report

Devices descending from K040019

97 later devices reach Silverseal through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063069Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC200773—
+1K063063Silvacide Skin & Wound Moisturizing SolutionMedical Molecular Therapuetics, LLC200714—
+1K061227Hydrolyzed Collagen/AG Wound Gel with SilverThe Hymed Group Corp.200621—
+2K151185AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser (Rx) and AGX Wound Wash…Abl Medical, LLC20160—
+2K111313Exsept Skin and Wound Cleanser with Antimicrobial PreservativeAlcavis Hdc, LLC20119—
+2K093227Silverstream and DermaseptEnzysurge, Ltd.20091—
+2K082858Exsept WC Antimicrobial Skin and Wound CleanserAlcavis International, Inc.20090—
+2K090160Suprathel Wound and Burn DressingPolymedics Innovations, GmbH200918—
+2K083355Wound Wash Saline, 210 ML, Model B8552, Wound Wash Saline, 90 ML, Model B8553Blairex Laboratories, Inc.200813—
+2K073019Silvermed Antimicrobial Silver HydrogelArgentis Biomedical Incorporated20081—
+2K073547Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound GelAnacapa Technologies, Inc.200866—
+3K200767SilverStream GelEnzysurge, Ltd.20200—
+3K183662Saline Wound Wash, SteriCleanse (TM)Ascent Consumer Products, Inc.20190—
+3K173544Phoenix Wound MatrixNanofiber Solutions, Inc.20180—
+3K170213SupraSDRM Biodegradable Matrix Wound DressingPolymedics Innovations, GmbH20170—
+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—
+3K142879BTM Wound DressingPolynovo Biomaterials Pty, Ltd.20155—
+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—
+3K132891Hydrolyzed Collagen/AG Wound Gel with SilverThe Hymed Group Corp.20140—
+3K132397Gore Bio-a Wound MatrixW. L. Gore & Associates, Inc.201410—
+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
+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—
+4K212521Field Shield Wound DressingKericure, Inc.20240—
+4K223377BIASURGE Advanced Surgical SolutionRochal Technologies, LLC20230—
+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—
+4K172140NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm)…Polynovo Biomaterials Pty, Ltd.20174—
+4K163430Prontosan Wound GelB.Braun Medical, Inc.20171—
+4K170300Restrata Wound MatrixAcera Surgical, Inc.201741
+4K161067Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen…Engineered Tissue Solutions, LLC20163—
+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—
+5K254256LUOFUCON® Wound MatrixHuizhou Foryou Medical Devices Co., Ltd.20260—
+5K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.20260—
+5K260020Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.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—
+5K251567NovoSorb BTMPolynovo Biomaterials Pty, Ltd.20250—
+5K233399Microdacyn Wound Care SolutionSonoma Pharmaceuticals, Inc.20241—
+5K240552Irrisept Antimicrobial Wound LavageIrrimax Corporation20240—
+5K232080Puracyn® Plus Antimicrobial Irrigation SolutionInnovacyn, Inc.20241—
+5K231937Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc.20232—
+5K231564Skin and Wound CleanserWinner Medical Co., Ltd.20230—
+5K223725Restrata® MiniMatrixAcera Surgical, Inc.20230—
+5K213514Spectricept Skin and Wound CleanserSpectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc.20231—
+5K220286ELECTROCYN somaV3Bio Sdn. Bhd20220—
+5K222189SiOxD Wound MatrixSioxmed, LLC20222—
+5K222804Irrisept Antimicrobial Wound LavageIrrimax Corporation20220—
+5K213616BD Surgiphor Antimicrobial Irrigation SystemBecton, Dickinson and Company20223—
+5K193583Restrata®Acera Surgical, Inc.202011
+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—
+6K243181Foundation Dermal Regeneration Scaffold Plus (DRS+) SoloBionova Medical, Inc.20240—
+6K240298Foundation Dermal Regeneration Scaffold Plus (DRS+) DuoBionova Medical, Inc.20241—
+6K241660SiOxD® Wound MatrixSioxmed, LLC20240—
+6K232847SiOxD Wound MatrixSioxmed, LLC20231—
+6K221504BD Surgiphor™ Antimicrobial Irrigation SystemBd20222—
+6K202071SURGIPHOR Wound Irrigation SystemOrthophor, LLC20204—
+7K253996BD Surgiphor™ Antimicrobial Irrigation System (910110)Becton, Dickinson and Company (BD)20260—
+7K253445BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)Bd20260—