510(k) Report

Devices descending from K945802

110 later devices reach Dermagran Wound Cleanser with Zinc through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080779Irrisept Wound Cleansing SystemIrrimax Corporation200992
+1K042084Bioderm Sciences Wound Healing SprayBioderm Sciences, Inc.200513—
+1K040683Bioderm Sciences Wound DressingBioderm Sciences, Inc.200429—
+1K040779Restore Wound CleanserHollister, Inc.200428—
+1K022670Carraklenz and UltraklenzCarrington Laboratories, Inc.2002105—
+1K970660Dermagran Wound Management SystemDerma Sciences, Inc.199712—
+1K965120Allclenz Wound CleanserDpt Laboratories, Ltd.1997107—
+2K202222Irrisept Wound Debridement and Cleansing SystemIrrimax Corporation20207—
+2K202071SURGIPHOR Wound Irrigation SystemOrthophor, LLC20204—
+2K143444SynePure Wound CleanserSynedgen, Inc.20150—
+2K141660Nawalution Skin and Wound CleanserNawa Heilmittel GmbH20142—
+2K092232Modification to:Vashe Wound Cleansing System, Model 9000-0014Puricore, Inc.200916—
+2K083355Wound Wash Saline, 210 ML, Model B8552, Wound Wash Saline, 90 ML, Model B8553Blairex Laboratories, Inc.200813—
+2K083042Wound Flush, Sterile Water & Normal SalineNurse Assist, Inc.20087Class I
+2K063069Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC200773—
+2K063063Silvacide Skin & Wound Moisturizing SolutionMedical Molecular Therapuetics, LLC200714—
+2K061467Exsept WC Wound CleanserAlcavis International, Inc.200711—
+2K060901Vashe Wound Cleansing SystemSterilox Technologies, Inc.20060—
+2K060113Dermacyn Wound CareOculus Innovative Sciences, Inc.200652—
+2K042352Bioderm Sciences Wound CreamBioderm Sciences, Inc.20051—
+2K042729Dermacyn Wound IrrigationOculus Innovative Sciences, Inc.200589—
+3K252759revyve® Antimicrobial Skin and Wound CleanserKane Biotech, Inc.20260—
+3K231564Skin and Wound CleanserWinner Medical Co., Ltd.20230—
+3K213616BD Surgiphor Antimicrobial Irrigation SystemBecton, Dickinson and Company20223—
+3K210536Irrisept Antimicrobial Wound LavageIrrimax Corporation20216—
+3K183662Saline Wound Wash, SteriCleanse (TM)Ascent Consumer Products, Inc.20190—
+3K181423AMSure Sterile Water, and Sterile Normal Saline for Wound FlushAmsino International, Inc.20180—
+3K173276Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USPMedline Industries, Inc.201811
+3K172486Anexa Wound Flush, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium…Anexa Biomedical, Inc.20171—
+3K170270Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal SalineLs Scientific Inc. D.B.A. Kse Scientific20170—
+3K161658Anexa Wound Flush, Sterile Water & Sterile Normal SalineAnexa Biomedical, Inc.20160—
+3K161311USP Sterile Water, 120 mL cup, USP Sterile Normal Saline (0.9% sodium chloride), 120 mL…Strukmyer Medical, LLC20162—
+3K151185AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser (Rx) and AGX Wound Wash…Abl Medical, LLC20160—
+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—
+3K111313Exsept Skin and Wound Cleanser with Antimicrobial PreservativeAlcavis Hdc, LLC20119—
+3K093227Silverstream and DermaseptEnzysurge, Ltd.20091—
+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—
+3K082858Exsept WC Antimicrobial Skin and Wound CleanserAlcavis International, Inc.20090—
+3K072876Prontosan Wound Irrigation SolutionB.Braun Medical, Inc.200829—
+3K070463Revera Wound Care, Model MDW0060Revalesio Corporation200822—
+3K073547Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound GelAnacapa Technologies, Inc.200866—
+3K071056Neutrophase Wound CleanserNovabay Pharmaceuticals200717—
+3K063805Silcryst Silver Antimicrobial Wound Cream, Model a-00901Nucryst Pharmaceuticals, Inc.20070—
+4K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLC20260—
+4K243415Granudacyn® Wound Irrigation SolutionP.G.F. Industry Solutions GmbH20251—
+4K243001Sterile Water USP and Sterile 0.9% Normal Saline USPLaboratorios Biogalenic S.A. DE C.V.20250—
+4K240552Irrisept Antimicrobial Wound LavageIrrimax Corporation20240—
+4K221504BD Surgiphor™ Antimicrobial Irrigation SystemBd20222—
+4K222804Irrisept Antimicrobial Wound LavageIrrimax Corporation20220—
+4K210987IRRIGO Wound Wash Jet SystemInopro, Inc.20220—
+4K200767SilverStream GelEnzysurge, Ltd.20200—
+4K180305Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC)Aquilabs Us, LLC20180—
+4K163188Next Science Wound Gel (Rx)Next Science, LLC20171—
+4K161623Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL…B.Braun Medical, Inc.20161—
+4K161165Next Science Irrigation SolutionNext Science, LLC20164—
+4K161034Microcyn Plus Wound Care SolutionOculus Innovative Sciences20163—
+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—
+4K142592CleanSmart Wound CleanserSimple Science, LLC20154—
+4K141863Puricore Wound Hydrogel Spray DressingPuricore, Inc.201510—
+4K141012Hydrocleanse Wound Care SolutionOculus Innovative Sciences20144—
+4K133542Puracyn Plus Skin and WoundInnovacyn, Inc.201414—
+4K113820Neutrophase Antimicrobial Wound CleanserNovabay Pharmaceuticals201215—
+4K110744Prontosan Wound Irrigation SolutionB.Braun Medical, Inc.20114—
+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—
+4K090206Oculus Puracyn Antimicrobial Skin and Wound CleanserOculus Innovative Sciences, Inc.2009373
+4K090141Prontosan Antimicrobial Wound GelB.Braun Medical, Inc.200922—
+4K081009NeutrophaseNovabay Pharmaceuticals200816—
+5K254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLC20260—
+5K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.20260—
+5K252028LUOFUCON® Antimicrobial Wound GelHuizhou Foryou Medical Co., Ltd.20260—
+5K253996BD Surgiphor™ Antimicrobial Irrigation System (910110)Becton, Dickinson and Company (BD)20260—
+5K253445BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)Bd20260—
+5K250642LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.)Huizhou Foryou Medical Devices Co., Ltd.20250—
+5K243457Nixall Antimicrobial Solutions™ Skin & Wound HydrogelSeriously Clean, Ltd.20250—
+5K212521Field Shield Wound DressingKericure, Inc.20240—
+5K232080Puracyn® Plus Antimicrobial Irrigation SolutionInnovacyn, Inc.20241—
+5K220759Armis VeriCyn Wound WashArmis Biopharma, Inc.20230—
+5K223377BIASURGE Advanced Surgical SolutionRochal Technologies, LLC20230—
+5K213514Spectricept Skin and Wound CleanserSpectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc.20231—
+5K203446TorrentX Wound WashNext Science, LLC20210—
+5K203835MIS SolutionNext Science, LLC20210—
+5K192349Bactisure Wound LavageNext Science, LLC20200—
+5K181428Clyra Wound Irrigation SolutionClyra Medical Technologies, Inc.20195—
+5K190224Medline Burn and Wound Dressing (OTC)Medline Industries, Inc.20190—
+5K181074Simple Science Antimicrobial Facial and Eyelid CleanserSimple Science, LLC20182—
+5K173911Medline Burn and Wound DressingMedline Industries, Inc.20182—
+5K171935Alevicyn SG Antimicrobial GelSonoma Pharmaceuticals, Inc.20171—
+5K172622Microcyn Antimicrobial Skin and Wound CleanserSonoma Pharmaceuticals20173—
+5K172851Microcyn Plus Antimicrobial Wound Care SolutionSonoma Pharmaceuticals, Inc.201701
+5K163430Prontosan Wound GelB.Braun Medical, Inc.20171—
+5K151168Nexodyn AOS Wound Care SolutionApr Applied Pharma Research SA20150—