510(k) Report

Devices descending from K060113

52 later devices reach Dermacyn Wound Care through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083042Wound Flush, Sterile Water & Normal SalineNurse Assist, Inc.20087Class I
+1K072876Prontosan Wound Irrigation SolutionB.Braun Medical, Inc.200829—
+1K071056Neutrophase Wound CleanserNovabay Pharmaceuticals200717—
+2K181423AMSure Sterile Water, and Sterile Normal Saline for Wound FlushAmsino International, Inc.20180—
+2K173276Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USPMedline Industries, Inc.201811
+2K172486Anexa Wound Flush, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium…Anexa Biomedical, Inc.20171—
+2K170270Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal SalineLs Scientific Inc. D.B.A. Kse Scientific20170—
+2K161623Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL…B.Braun Medical, Inc.20161—
+2K161658Anexa Wound Flush, Sterile Water & Sterile Normal SalineAnexa Biomedical, Inc.20160—
+2K161165Next Science Irrigation SolutionNext Science, LLC20164—
+2K161311USP Sterile Water, 120 mL cup, USP Sterile Normal Saline (0.9% sodium chloride), 120 mL…Strukmyer Medical, LLC20162—
+2K141660Nawalution Skin and Wound CleanserNawa Heilmittel GmbH20142—
+2K110744Prontosan Wound Irrigation SolutionB.Braun Medical, Inc.20114—
+2K090141Prontosan Antimicrobial Wound GelB.Braun Medical, Inc.200922—
+2K081009NeutrophaseNovabay Pharmaceuticals200816—
+3K252759revyve® Antimicrobial Skin and Wound CleanserKane Biotech, Inc.20260—
+3K250642LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.)Huizhou Foryou Medical Devices Co., Ltd.20250—
+3K243001Sterile Water USP and Sterile 0.9% Normal Saline USPLaboratorios Biogalenic S.A. DE C.V.20250—
+3K231564Skin and Wound CleanserWinner Medical Co., Ltd.20230—
+3K220759Armis VeriCyn Wound WashArmis Biopharma, Inc.20230—
+3K203446TorrentX Wound WashNext Science, LLC20210—
+3K203835MIS SolutionNext Science, LLC20210—
+3K192349Bactisure Wound LavageNext Science, LLC20200—
+3K113820Neutrophase Antimicrobial Wound CleanserNovabay Pharmaceuticals201215—
+3K101882Prontosan Antimicrobial Wound GelB.Braun Medical, Inc.201021—
+4K190224Medline Burn and Wound Dressing (OTC)Medline Industries, Inc.20190—
+4K173911Medline Burn and Wound DressingMedline Industries, Inc.20182—
+4K180305Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC)Aquilabs Us, LLC20180—
+4K163430Prontosan Wound GelB.Braun Medical, Inc.20171—
+4K151168Nexodyn AOS Wound Care SolutionApr Applied Pharma Research SA20150—
+4K141863Puricore Wound Hydrogel Spray DressingPuricore, Inc.201510—
+4K131848Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ)Puricore, Inc.20148—
+4K131542Neutrophase (R) Skin and Wound Cleanser OtcNovabay Pharmaceuticals, Inc.20133—
+5K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbH20260—
+5K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLC20260—
+5K254191IWD-Gel™InnovaCorium, Inc.20260—
+5K243415Granudacyn® Wound Irrigation SolutionP.G.F. Industry Solutions GmbH20251—
+5K161034Microcyn Plus Wound Care SolutionOculus Innovative Sciences20163—
+5K150799Puracyn (R) Plus Duo-Care (TM) Antimicrobial Wound & Skin Hydrogel, Puracyn (R) Plus…Innovacyn, Inc.20159—
+5K141012Hydrocleanse Wound Care SolutionOculus Innovative Sciences20144—
+6K254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLC20260—
+6K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.20260—
+6K243457Nixall Antimicrobial Solutions™ Skin & Wound HydrogelSeriously Clean, Ltd.20250—
+6K212521Field Shield Wound DressingKericure, Inc.20240—
+6K213514Spectricept Skin and Wound CleanserSpectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc.20231—
+6K171935Alevicyn SG Antimicrobial GelSonoma Pharmaceuticals, Inc.20171—
+6K172851Microcyn Plus Antimicrobial Wound Care SolutionSonoma Pharmaceuticals, Inc.201701
+6K160095Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science Antimicrobial…Simple Science, LLC20163—
+7K243875Spectricept Skin and Wound CleanserSpectrum Antimicrobials, Inc.20250—
+7K181074Simple Science Antimicrobial Facial and Eyelid CleanserSimple Science, LLC20182—
+7K173896Microcyn Antimicrobial HydrogelSonoma Pharmaceuticals, Inc.20180—
+8K233399Microdacyn Wound Care SolutionSonoma Pharmaceuticals, Inc.20241—