510(k) Report

Devices descending from K131848

8 later devices reach Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLC20260—
+1K243415Granudacyn® Wound Irrigation SolutionP.G.F. Industry Solutions GmbH20251—
+1K161034Microcyn Plus Wound Care SolutionOculus Innovative Sciences20163—
+1K141012Hydrocleanse Wound Care SolutionOculus Innovative Sciences20144—
+2K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.20260—
+2K213514Spectricept Skin and Wound CleanserSpectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc.20231—
+2K172851Microcyn Plus Antimicrobial Wound Care SolutionSonoma Pharmaceuticals, Inc.201701
+3K243875Spectricept Skin and Wound CleanserSpectrum Antimicrobials, Inc.20250—