510(k) Report

Devices descending from K984388

90 later devices reach HA Absorbent Wound Dressing through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K033666HemadermMedafor, Inc.200329—
+1K020325L.a.M. Ipm Wound GelL.A.M. Pharmaceutical, Corp.200259—
+2K123193Ipm Wound Gel BioGlycobiosciences, Inc.20141—
+2K130781L.a.M. Ipm Wound Gel, Ipm Derm GelGlycobiosciences, Inc.20141—
+2K123113L.a.M. Imp Wound GelGlycobiosciences, Inc.20122Class I
+2K122886Nexstat Plus and Nexfoam Plus Topical Hemostat DressingHemostasis, LLC20120—
+2K102459Nexstat (TM) Topical Hemostat Powder; Nexfoam (R) Topical SpongeHemostasis, LLC20109—
+2K090725Oculus Microcyn Wound GelOculus Innovative Sciences, Inc.200956—
+2K080818Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical DressingHem Con Medical Technologies, Inc.200811—
+2K070211Traumarrest and Bleedarrest Hemostatic Particles and FoamHemostasis, LLC200728—
+3K150916HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO…Hem Con Medical Technologies, Inc.20153—
+3K151204HEMO-BandageCoreleader Biotech Co., Ltd.20150—
+3K143527IPM Wound Gel Bio, IPM Derm Gel BioGlycobiosciences, Inc.20150—
+3K140313Stopsbleeding Topical Hemostat Powder and FoamCoag Medical, LLC20141—
+3K132105Perclot TopicalCryolife, Inc.20140—
+3K120958Posisep and Posisep X Hemostat DressingsHemostasis, LLC20126—
+3K102742Nasal CeaseCatalina, Inc.20111—
+3K100918Vashe Wound Therapy System Model: 9000-0014Puricore, Inc.201031—
+3K093697Vashe Wound Therapy SolutionPuricore, Inc.201020—
+3K093585Microcyn Skin and Wound HydrogelOculus Innovative Sciences, Inc.2010251
+3K093155Vashe Wound Cleansing SystemPuricore, Inc.20100—
+3K093519Medtrade Products Celox Vascular Topical Hemostatic Granules on SheetMedtrade Products, Ltd.20102—
+3K090620Quikclot Inteventional, Model P/N 182Z-Medica Corporation20095—
+3K082601UltraClot, UltraClot OTCEmergency Medical Devices, LLC20080—
+3K072900Excelarrest FoamHemostasis, LLC200719—
+4K240510Microdacyn HydrogelSonoma Pharmaceuticals, Inc.20240—
+4K240097Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5)Ushare Medical, Inc.20240—
+4K202830Axiostat PatchAdvamedica, Inc.20210—
+4K190012OMNI-STAT Vascular (Rapid); CELOX Vascular RapidMedtrade Product, Ltd.20190—
+4K183622NasalCEASE and BleedCEASELes Laboratoires Brothier S.A.20190—
+4K182811gel-e Flex+Gel-E, Inc.20191—
+4K172155StatGuard Hemostatic Patch, StatGuard Hemostatic DressingStatguard, LLC20180—
+4K153648Microcyn Plus Skin and Wound HydrogelOculus Innovative Sciences20166—
+4K150799Puracyn (R) Plus Duo-Care (TM) Antimicrobial Wound & Skin Hydrogel, Puracyn (R) Plus…Innovacyn, Inc.20159—
+4K142592CleanSmart Wound CleanserSimple Science, LLC20154—
+4K141863Puricore Wound Hydrogel Spray DressingPuricore, Inc.201510—
+4K141704Novashield Injectable Nasal Packing and StentMedtronic, Inc.20142—
+4K141012Hydrocleanse Wound Care SolutionOculus Innovative Sciences20144—
+4K133542Puracyn Plus Skin and WoundInnovacyn, Inc.201414—
+4K122494Posisep and Posisep X Hemostat Dressing/Intranasal SplintHemostasis, LLC20132—
+4K120782Interventional Hemostatic BandageZ-Medica Corporation20131—
+4K123072Vashe Wound Therapy SolutionPuricore, Inc.201325—
+4K113820Neutrophase Antimicrobial Wound CleanserNovabay Pharmaceuticals201215—
+4K102945Pediacyn Atopic Dermatitis HydrogelOculus Innovative Sciences, Inc.201117—
+5K254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLC20260—
+5K252023MiraChlor Antimicrobial Wound SolutionLetus Corporation20260—
+5K243457Nixall Antimicrobial Solutions™ Skin & Wound HydrogelSeriously Clean, Ltd.20250—
+5K212521Field Shield Wound DressingKericure, Inc.20240—
+5K232080Puracyn® Plus Antimicrobial Irrigation SolutionInnovacyn, Inc.20241—
+5K192667gel-e Flex+ gel OTCGel-E, Inc.20190—
+5K181428Clyra Wound Irrigation SolutionClyra Medical Technologies, Inc.20195—
+5K181641QuikClot RadialZ-Medica, LLC20180—
+5K181696ChitoZolveGyrus Acmi, Inc.20180—
+5K173549BiafineValeant Pharmaceuticals20184—
+5K180305Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC)Aquilabs Us, LLC20180—
+5K173896Microcyn Antimicrobial HydrogelSonoma Pharmaceuticals, Inc.20180—
+5K171935Alevicyn SG Antimicrobial GelSonoma Pharmaceuticals, Inc.20171—
+5K172179Chitogel Endoscopic Sinus Surgery KitChitogel, Ltd.20171—
+5K161034Microcyn Plus Wound Care SolutionOculus Innovative Sciences20163—
+5K160095Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science Antimicrobial…Simple Science, LLC20163—
+5K151168Nexodyn AOS Wound Care SolutionApr Applied Pharma Research SA20150—
+5K143590Alevicyn SG Antipruritic GelOculus Innovative Sciences20154—
+5K141660Nawalution Skin and Wound CleanserNawa Heilmittel GmbH20142—
+5K141816HemoporePolyganics B.V.,20140—
+5K131848Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ)Puricore, Inc.20148—
+5K131542Neutrophase (R) Skin and Wound Cleanser OtcNovabay Pharmaceuticals, Inc.20133—
+5K123071Vashe Skin and Wound HydrogelPuricore, Inc.201311—
+6K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLC20260—
+6K252759revyve® Antimicrobial Skin and Wound CleanserKane Biotech, Inc.20260—
+6K251757Puracyn® Plus Antimicrobial Irrigation SolutionInnovacyn, Inc.20260—
+6K243415Granudacyn® Wound Irrigation SolutionP.G.F. Industry Solutions GmbH20251—
+6K251093Bonvadis®Oneness Biotech Co., Ltd.20251—
+6K232655Bonvadis®Stemcyte, Inc.20242—
+6K231564Skin and Wound CleanserWinner Medical Co., Ltd.20230—
+6K230142Epi-Stop Nasal Gel/epistaxis packBiomed Ent, Inc.20230—
+6K213514Spectricept Skin and Wound CleanserSpectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc.20231—
+6K202071SURGIPHOR Wound Irrigation SystemOrthophor, LLC20204—
+6K190342BIAFINE Topical CreamBausch Health Americas Incorporated20190—
+6K181074Simple Science Antimicrobial Facial and Eyelid CleanserSimple Science, LLC20182—
+6K172851Microcyn Plus Antimicrobial Wound Care SolutionSonoma Pharmaceuticals, Inc.201701
+6K152945Alevicyn SG Antipruritic GelOculus Innovative Sciences20153—
+7K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.20260—
+7K261638Bonvadis®Oneness Biotech Co., Ltd.20260—
+7K243875Spectricept Skin and Wound CleanserSpectrum Antimicrobials, Inc.20250—
+7K233399Microdacyn Wound Care SolutionSonoma Pharmaceuticals, Inc.20241—
+7K213616BD Surgiphor Antimicrobial Irrigation SystemBecton, Dickinson and Company20223—
+7K162217LOYONOculus Innovative Sciences20170—
+8K221504BD Surgiphor™ Antimicrobial Irrigation SystemBd20222—
+9K253996BD Surgiphor™ Antimicrobial Irrigation System (910110)Becton, Dickinson and Company (BD)20260—
+9K253445BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)Bd20260—