510(k) Report

Devices descending from K070463

22 later devices reach Revera Wound Care, Model MDW0060 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083355Wound Wash Saline, 210 ML, Model B8552, Wound Wash Saline, 90 ML, Model B8553Blairex Laboratories, Inc.200813—
+1K083042Wound Flush, Sterile Water & Normal SalineNurse Assist, Inc.20087Class I
+2K183662Saline Wound Wash, SteriCleanse (TM)Ascent Consumer Products, Inc.20190—
+2K181423AMSure Sterile Water, and Sterile Normal Saline for Wound FlushAmsino International, Inc.20180—
+2K173276Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USPMedline Industries, Inc.201811
+2K172486Anexa Wound Flush, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium…Anexa Biomedical, Inc.20171—
+2K170270Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal SalineLs Scientific Inc. D.B.A. Kse Scientific20170—
+2K161658Anexa Wound Flush, Sterile Water & Sterile Normal SalineAnexa Biomedical, Inc.20160—
+2K161311USP Sterile Water, 120 mL cup, USP Sterile Normal Saline (0.9% sodium chloride), 120 mL…Strukmyer Medical, LLC20162—
+2K131848Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ)Puricore, Inc.20148—
+2K123910Woundwash Saline SprayNeilmed Pharmaceuticals, Inc.20130—
+2K090848Premier Sterile Saline Wound Wash, Models 210 ML, WWMPremier Brands of America, Inc.20091—
+3K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLC20260—
+3K243415Granudacyn® Wound Irrigation SolutionP.G.F. Industry Solutions GmbH20251—
+3K243001Sterile Water USP and Sterile 0.9% Normal Saline USPLaboratorios Biogalenic S.A. DE C.V.20250—
+3K210987IRRIGO Wound Wash Jet SystemInopro, Inc.20220—
+3K161034Microcyn Plus Wound Care SolutionOculus Innovative Sciences20163—
+3K141012Hydrocleanse Wound Care SolutionOculus Innovative Sciences20144—
+4K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.20260—
+4K213514Spectricept Skin and Wound CleanserSpectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc.20231—
+4K172851Microcyn Plus Antimicrobial Wound Care SolutionSonoma Pharmaceuticals, Inc.201701
+5K243875Spectricept Skin and Wound CleanserSpectrum Antimicrobials, Inc.20250—