510(k) Report

Devices descending from K955453

161 later devices reach Acticoat Silver Coated Dressing through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K100918Vashe Wound Therapy System Model: 9000-0014Puricore, Inc.201031—
+5K093697Vashe Wound Therapy SolutionPuricore, Inc.201020—
+5K093155Vashe Wound Cleansing SystemPuricore, Inc.20100—
+5K090791Dakin's Antimicrobial Wound Cleanser, Model 0.0125% to 5%Century Pharmaceuticals, Inc.200910—
+5K090848Premier Sterile Saline Wound Wash, Models 210 ML, WWMPremier Brands of America, Inc.20091—
+5K090206Oculus Puracyn Antimicrobial Skin and Wound CleanserOculus Innovative Sciences, Inc.2009373
+6K254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLC20260—
+6K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLC20260—
+6K252028LUOFUCON® Antimicrobial Wound GelHuizhou Foryou Medical Co., Ltd.20260—
+6K252759revyve® Antimicrobial Skin and Wound CleanserKane Biotech, Inc.20260—
+6K243415Granudacyn® Wound Irrigation SolutionP.G.F. Industry Solutions GmbH20251—
+6K243457Nixall Antimicrobial Solutions™ Skin & Wound HydrogelSeriously Clean, Ltd.20250—
+6K243181Foundation Dermal Regeneration Scaffold Plus (DRS+) SoloBionova Medical, Inc.20240—
+6K240298Foundation Dermal Regeneration Scaffold Plus (DRS+) DuoBionova Medical, Inc.20241—
+6K241225Silverlon® Wound Contact, Burn Contact DressingArgentum Medical, LLC20240—
+6K231088Copper Foam Dressing (Prescription and OTC)Roosin Medical Co., Ltd.20240—
+6K223377BIASURGE Advanced Surgical SolutionRochal Technologies, LLC20230—
+6K220673Sterile Silver Alginate Wound DressingQingdao Bright Moon Biomedical Materials Co., Ltd.20230—
+6K221754Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone Ag Foam…Winner Medical Co., Ltd.20230—
+6K210987IRRIGO Wound Wash Jet SystemInopro, Inc.20220—
+6K210536Irrisept Antimicrobial Wound LavageIrrimax Corporation20216—
+6K190224Medline Burn and Wound Dressing (OTC)Medline Industries, Inc.20190—
+6K181074Simple Science Antimicrobial Facial and Eyelid CleanserSimple Science, LLC20182—
+6K173911Medline Burn and Wound DressingMedline Industries, Inc.20182—
+6K180305Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC)Aquilabs Us, LLC20180—
+6K171935Alevicyn SG Antimicrobial GelSonoma Pharmaceuticals, Inc.20171—
+6K172622Microcyn Antimicrobial Skin and Wound CleanserSonoma Pharmaceuticals20173—
+6K163430Prontosan Wound GelB.Braun Medical, Inc.20171—
+6K161034Microcyn Plus Wound Care SolutionOculus Innovative Sciences20163—
+6K160022LUOFUCON Silicone Ag foam dressingHuizhou Foryou Medical Devices Co., Ltd.20163—
+6K151168Nexodyn AOS Wound Care SolutionApr Applied Pharma Research SA20150—
+6K142592CleanSmart Wound CleanserSimple Science, LLC20154—
+6K141660Nawalution Skin and Wound CleanserNawa Heilmittel GmbH20142—
+6K141012Hydrocleanse Wound Care SolutionOculus Innovative Sciences20144—
+6K133542Puracyn Plus Skin and WoundInnovacyn, Inc.201414—
+6K131542Neutrophase (R) Skin and Wound Cleanser OtcNovabay Pharmaceuticals, Inc.20133—
+6K123072Vashe Wound Therapy SolutionPuricore, Inc.201325—
+6K110744Prontosan Wound Irrigation SolutionB.Braun Medical, Inc.20114—
+7K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbH20260—
+7K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.20260—
+7K254191IWD-Gel™InnovaCorium, Inc.20260—
+7K252023MiraChlor Antimicrobial Wound SolutionLetus Corporation20260—
+7K250642LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.)Huizhou Foryou Medical Devices Co., Ltd.20250—
+7K233399Microdacyn Wound Care SolutionSonoma Pharmaceuticals, Inc.20241—
+7K240552Irrisept Antimicrobial Wound LavageIrrimax Corporation20240—
+7K232080Puracyn® Plus Antimicrobial Irrigation SolutionInnovacyn, Inc.20241—
+7K231564Skin and Wound CleanserWinner Medical Co., Ltd.20230—
+7K213514Spectricept Skin and Wound CleanserSpectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc.20231—
+7K220286ELECTROCYN somaV3Bio Sdn. Bhd20220—
+7K222804Irrisept Antimicrobial Wound LavageIrrimax Corporation20220—
+7K213616BD Surgiphor Antimicrobial Irrigation SystemBecton, Dickinson and Company20223—
+7K181428Clyra Wound Irrigation SolutionClyra Medical Technologies, Inc.20195—
+7K173896Microcyn Antimicrobial HydrogelSonoma Pharmaceuticals, Inc.20180—
+7K172851Microcyn Plus Antimicrobial Wound Care SolutionSonoma Pharmaceuticals, Inc.201701
+7K170077LUOFUCON Silicone Ag Foam Dressing with BorderHuizhou Foryou Medical Devices Co., Ltd.20172—
+8K251757Puracyn® Plus Antimicrobial Irrigation SolutionInnovacyn, Inc.20260—
+8K243875Spectricept Skin and Wound CleanserSpectrum Antimicrobials, Inc.20250—
+8K221504BD Surgiphor™ Antimicrobial Irrigation SystemBd20222—
+8K202071SURGIPHOR Wound Irrigation SystemOrthophor, LLC20204—
+9K253996BD Surgiphor™ Antimicrobial Irrigation System (910110)Becton, Dickinson and Company (BD)20260—
+9K253445BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)Bd20260—