510(k) Report

Devices descending from K092232

16 later devices reach Modification to:Vashe Wound Cleansing System, Model 9000-0014 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113693Nixall TM Wound and Skin CareSeriously Clean, Ltd.201215—
+2K180305Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC)Aquilabs Us, LLC20180—
+2K142592CleanSmart Wound CleanserSimple Science, LLC20154—
+2K133542Puracyn Plus Skin and WoundInnovacyn, Inc.201414—
+3K232080Puracyn® Plus Antimicrobial Irrigation SolutionInnovacyn, Inc.20241—
+3K181428Clyra Wound Irrigation SolutionClyra Medical Technologies, Inc.20195—
+3K160095Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science Antimicrobial…Simple Science, LLC20163—
+4K251757Puracyn® Plus Antimicrobial Irrigation SolutionInnovacyn, Inc.20260—
+4K202071SURGIPHOR Wound Irrigation SystemOrthophor, LLC20204—
+4K181074Simple Science Antimicrobial Facial and Eyelid CleanserSimple Science, LLC20182—
+5K233399Microdacyn Wound Care SolutionSonoma Pharmaceuticals, Inc.20241—
+5K213616BD Surgiphor Antimicrobial Irrigation SystemBecton, Dickinson and Company20223—
+6K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.20260—
+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—