510(k) Report

Devices descending from K981299

149 later devices reach Silverlon Contact Wound Dressing through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K243181Foundation Dermal Regeneration Scaffold Plus (DRS+) SoloBionova Medical, Inc.20240—
+5K240298Foundation Dermal Regeneration Scaffold Plus (DRS+) DuoBionova Medical, Inc.20241—
+5K241225Silverlon® Wound Contact, Burn Contact DressingArgentum Medical, LLC20240—
+5K231088Copper Foam Dressing (Prescription and OTC)Roosin Medical Co., Ltd.20240—
+5K223377BIASURGE Advanced Surgical SolutionRochal Technologies, LLC20230—
+5K220673Sterile Silver Alginate Wound DressingQingdao Bright Moon Biomedical Materials Co., Ltd.20230—
+5K221754Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone Ag Foam…Winner Medical Co., Ltd.20230—
+5K210987IRRIGO Wound Wash Jet SystemInopro, Inc.20220—
+5K210536Irrisept Antimicrobial Wound LavageIrrimax Corporation20216—
+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—
+5K180305Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC)Aquilabs Us, LLC20180—
+5K171935Alevicyn SG Antimicrobial GelSonoma Pharmaceuticals, Inc.20171—
+5K172622Microcyn Antimicrobial Skin and Wound CleanserSonoma Pharmaceuticals20173—
+5K163430Prontosan Wound GelB.Braun Medical, Inc.20171—
+5K161034Microcyn Plus Wound Care SolutionOculus Innovative Sciences20163—
+5K160022LUOFUCON Silicone Ag foam dressingHuizhou Foryou Medical Devices Co., Ltd.20163—
+5K151168Nexodyn AOS Wound Care SolutionApr Applied Pharma Research SA20150—
+5K142592CleanSmart Wound CleanserSimple Science, LLC20154—
+5K141660Nawalution Skin and Wound CleanserNawa Heilmittel GmbH20142—
+5K141012Hydrocleanse Wound Care SolutionOculus Innovative Sciences20144—
+5K133542Puracyn Plus Skin and WoundInnovacyn, Inc.201414—
+5K131542Neutrophase (R) Skin and Wound Cleanser OtcNovabay Pharmaceuticals, Inc.20133—
+5K123072Vashe Wound Therapy SolutionPuricore, Inc.201325—
+5K110744Prontosan Wound Irrigation SolutionB.Braun Medical, Inc.20114—
+6K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbH20260—
+6K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.20260—
+6K254191IWD-Gel™InnovaCorium, Inc.20260—
+6K252023MiraChlor Antimicrobial Wound SolutionLetus Corporation20260—
+6K250642LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.)Huizhou Foryou Medical Devices Co., Ltd.20250—
+6K233399Microdacyn Wound Care SolutionSonoma Pharmaceuticals, Inc.20241—
+6K240552Irrisept Antimicrobial Wound LavageIrrimax Corporation20240—
+6K232080Puracyn® Plus Antimicrobial Irrigation SolutionInnovacyn, Inc.20241—
+6K231564Skin and Wound CleanserWinner Medical Co., Ltd.20230—
+6K213514Spectricept Skin and Wound CleanserSpectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc.20231—
+6K220286ELECTROCYN somaV3Bio Sdn. Bhd20220—
+6K222804Irrisept Antimicrobial Wound LavageIrrimax Corporation20220—
+6K213616BD Surgiphor Antimicrobial Irrigation SystemBecton, Dickinson and Company20223—
+6K181428Clyra Wound Irrigation SolutionClyra Medical Technologies, Inc.20195—
+6K173896Microcyn Antimicrobial HydrogelSonoma Pharmaceuticals, Inc.20180—
+6K172851Microcyn Plus Antimicrobial Wound Care SolutionSonoma Pharmaceuticals, Inc.201701
+6K170077LUOFUCON Silicone Ag Foam Dressing with BorderHuizhou Foryou Medical Devices Co., Ltd.20172—
+7K251757Puracyn® Plus Antimicrobial Irrigation SolutionInnovacyn, Inc.20260—
+7K243875Spectricept Skin and Wound CleanserSpectrum Antimicrobials, Inc.20250—
+7K221504BD Surgiphor™ Antimicrobial Irrigation SystemBd20222—
+7K202071SURGIPHOR Wound Irrigation SystemOrthophor, LLC20204—
+8K253996BD Surgiphor™ Antimicrobial Irrigation System (910110)Becton, Dickinson and Company (BD)20260—
+8K253445BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)Bd20260—