510(k) Report

Devices descending from K041161

41 later devices reach Microcyn Wound Care Dressing through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093697Vashe Wound Therapy SolutionPuricore, Inc.201020—
+1K092232Modification to:Vashe Wound Cleansing System, Model 9000-0014Puricore, Inc.200916—
+1K090848Premier Sterile Saline Wound Wash, Models 210 ML, WWMPremier Brands of America, Inc.20091—
+1K070463Revera Wound Care, Model MDW0060Revalesio Corporation200822—
+1K060901Vashe Wound Cleansing SystemSterilox Technologies, Inc.20060—
+2K210987IRRIGO Wound Wash Jet SystemInopro, Inc.20220—
+2K142592CleanSmart Wound CleanserSimple Science, LLC20154—
+2K141012Hydrocleanse Wound Care SolutionOculus Innovative Sciences20144—
+2K133542Puracyn Plus Skin and WoundInnovacyn, Inc.201414—
+2K113693Nixall TM Wound and Skin CareSeriously Clean, Ltd.201215—
+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
+3K232080Puracyn® Plus Antimicrobial Irrigation SolutionInnovacyn, Inc.20241—
+3K181428Clyra Wound Irrigation SolutionClyra Medical Technologies, Inc.20195—
+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
+3K180305Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC)Aquilabs Us, LLC20180—
+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—
+3K161034Microcyn Plus Wound Care SolutionOculus Innovative Sciences20163—
+3K160095Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science Antimicrobial…Simple Science, LLC20163—
+3K131848Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ)Puricore, Inc.20148—
+3K123910Woundwash Saline SprayNeilmed Pharmaceuticals, Inc.20130—
+4K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLC20260—
+4K251757Puracyn® Plus Antimicrobial Irrigation SolutionInnovacyn, Inc.20260—
+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—
+4K213514Spectricept Skin and Wound CleanserSpectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc.20231—
+4K202071SURGIPHOR Wound Irrigation SystemOrthophor, LLC20204—
+4K181074Simple Science Antimicrobial Facial and Eyelid CleanserSimple Science, LLC20182—
+4K172851Microcyn Plus Antimicrobial Wound Care SolutionSonoma Pharmaceuticals, Inc.201701
+5K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.20260—
+5K243875Spectricept Skin and Wound CleanserSpectrum Antimicrobials, Inc.20250—
+5K233399Microdacyn Wound Care SolutionSonoma Pharmaceuticals, Inc.20241—
+5K213616BD Surgiphor Antimicrobial Irrigation SystemBecton, Dickinson and Company20223—
+6K221504BD Surgiphor™ Antimicrobial Irrigation SystemBd20222—
+7K253996BD Surgiphor™ Antimicrobial Irrigation System (910110)Becton, Dickinson and Company (BD)20260—
+7K253445BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)Bd20260—