510(k) Report

Devices descending from K024367

67 later devices reach Sinclair Wound and Skin Emulsion through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152533Xonrid GelHelsinn Healthcare SA20160—
+1K102945Pediacyn Atopic Dermatitis HydrogelOculus Innovative Sciences, Inc.201117—
+1K093156Pruclair Nonsteroidal CreamPrugen IP Holdings, Inc.20100—
+1K092297Eletone CreamFerndale Pharma Group, Inc.20090—
+1K083024Hylatopic Emollient FoamCollegium Pharmaceutical Incorporated20098—
+1K071483Tetrix CreamCoria Laboratories, Ltd.20082—
+1K060272Locobase Wound and Skin EmulsionFerndale Laboratories, Inc.200710—
+1K050158Sinclair Seborrhea EmulsionSinclair Pharmaceuticals, Ltd.20069—
+1K052643EpiceramCeragenix Corporation200616—
+1K041342Impruv a.I. Cream Wound and Skin EmulsionStiefel Laboratories, Inc.200544—
+2K252568New Day Skin SpraySilk Holdings, Inc.20260—
+2K242406SiOxC CreamSioxmed, LLC20251—
+2K171879HylaGuard Moisturizing CreamFounders Science Group, LLC20170—
+2K171191Hexagen DermGlobal Health Solutions, LLC20170—
+2K143605Nutraseb Facial CreamIsdin Corp.20160—
+2K152055Ceramax Skin Barrier CreamOculus Innovative Sciences201501
+2K150799Puracyn (R) Plus Duo-Care (TM) Antimicrobial Wound & Skin Hydrogel, Puracyn (R) Plus…Innovacyn, Inc.20159—
+2K143590Alevicyn SG Antipruritic GelOculus Innovative Sciences20154—
+2K141637SPB Skin EmulsionBiotd S.A.20150—
+2K140905DermafineInvado Pharmaceuticals20150—
+2K130781L.a.M. Ipm Wound Gel, Ipm Derm GelGlycobiosciences, Inc.20141—
+2K123724Dermiseb CreamIgi Laboratories, Inc.20134—
+2K123071Vashe Skin and Wound HydrogelPuricore, Inc.201311—
+2K120730Loutrex Topical CreamAcella Pharmaceuticals, LLC20124—
+2K121134TL Triseb CreamTrigen Laboratories, Inc.20124—
+2K113807Dexeryl CreamPierre Fabre Medical Devices20120—
+2K113772HPR Emollient FoamPrugen IP Holdings, Inc.20120—
+2K111168Precision Skin EmulsionPrecision Dermatology Incorporated20115—
+2K110172Sonafine Wound DressingStratus Pharmaceutical20112—
+2K110757TL-Cermide Skin Barrier EmulsionTrigen Laboratories, Inc.20111—
+2K110732Emulsion SBPrugen IP Holdings, Inc.20110—
+2K093159PR CreamPrugen IP Holdings, Inc.20100—
+2K093544Tropazone CRMidlothian Laboratories20101—
+2K093051Hylatopic Plus Emollient FoamCollegium Pharmaceutical Incorporated20096—
+2K090337Tropazone LotionMidlothian Laboratories20093—
+2K082089Prumyx CreamPrugen, Inc.20093—
+2K070309NeosalusQuinnova Pharmaceuticals20085—
+2K073246ZenievaGorbec Pharmaceutical Services, Inc.20087—
+2K080471Radio BioaquacareBioartificial Gel Technologies (Bagtech), Inc.20080—
+3K254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLC20260—
+3K250890SBC1 CreamSioxmed, LLC20260—
+3K243457Nixall Antimicrobial Solutions™ Skin & Wound HydrogelSeriously Clean, Ltd.20250—
+3K212521Field Shield Wound DressingKericure, Inc.20240—
+3K233151PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and Wound Dressing (OTC)Medline Industries, LP20240—
+3K171935Alevicyn SG Antimicrobial GelSonoma Pharmaceuticals, Inc.20171—
+3K162217LOYONOculus Innovative Sciences20170—
+3K160095Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science Antimicrobial…Simple Science, LLC20163—
+3K152945Alevicyn SG Antipruritic GelOculus Innovative Sciences20153—
+3K141863Puricore Wound Hydrogel Spray DressingPuricore, Inc.201510—
+3K143527IPM Wound Gel Bio, IPM Derm Gel BioGlycobiosciences, Inc.20150—
+3K113774HPR Plus Emollient FoamPrugen IP Holdings, Inc.20121—
+3K110727Hylatopicplus CreamPrecision Dermatology Incorporated20114—
+3K090585Neosalus CreamQuinnova Pharmaceuticals20094—
+3K082865Modification to ZenievaGorbec Pharmaceutical Services, Inc.20082—
+4K240722Derma-R Cream (Derma-R Cream)Raya Pharmaceuticals, LLC20240—
+4K181074Simple Science Antimicrobial Facial and Eyelid CleanserSimple Science, LLC20182—
+4K173896Microcyn Antimicrobial HydrogelSonoma Pharmaceuticals, Inc.20180—
+4K170911NEOCERA Advanced Barrier CreamExeltis USA Dermatology, LLC20170—
+4K150914Dash-Topic Plus CreamFounders Science Group, LLC20160—
+4K132329Nivatopic PlusNivagen Pharmaceuticals, Inc.20130—
+4K123678Hyalmix CreamIgi Laboratories, Inc.20130—
+4K121559Hylatopicplus LotionPrecision Dermatology Incorporated20120—
+4K091719Neosalus LotionQuinnova Pharmaceuticals20090—
+4K083721Modification to ZenievaRiver'S Edge Pharmaceuticals, LLC20091—
+5K233399Microdacyn Wound Care SolutionSonoma Pharmaceuticals, Inc.20241—
+5K100839BarirepGorbec Pharmaceutical Services, Inc.20100—
+6K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.20260—