510(k) Report

Devices descending from K083355

13 later devices reach Wound Wash Saline, 210 ML, Model B8552, Wound Wash Saline, 90 ML, Model B8553 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183662Saline Wound Wash, SteriCleanse (TM)Ascent Consumer Products, Inc.20190—
+1K131848Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ)Puricore, Inc.20148—
+1K123910Woundwash Saline SprayNeilmed Pharmaceuticals, Inc.20130—
+1K090848Premier Sterile Saline Wound Wash, Models 210 ML, WWMPremier Brands of America, Inc.20091—
+2K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLC20260—
+2K243415Granudacyn® Wound Irrigation SolutionP.G.F. Industry Solutions GmbH20251—
+2K210987IRRIGO Wound Wash Jet SystemInopro, Inc.20220—
+2K161034Microcyn Plus Wound Care SolutionOculus Innovative Sciences20163—
+2K141012Hydrocleanse Wound Care SolutionOculus Innovative Sciences20144—
+3K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.20260—
+3K213514Spectricept Skin and Wound CleanserSpectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc.20231—
+3K172851Microcyn Plus Antimicrobial Wound Care SolutionSonoma Pharmaceuticals, Inc.201701
+4K243875Spectricept Skin and Wound CleanserSpectrum Antimicrobials, Inc.20250—