510(k) Report

Devices descending from K002896

83 later devices reach Acticoat Foam Dressing, Algisite M Calcium Alginate Dressing through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070581Silver Alginate II Wound DressingAdvanced Medical Solutions Limited20073—
+1K053590Silverlon CA (Calcium Alginate)Argentum Medical, LLC20061—
+1K041316Antimicrobial Alginate DressingAdvanced Medical Solutions, Ltd.200416—
+1K024298Antimicrobial Alginate DressingAdvanced Medical Solutions, Ltd.200353—
+1K022483Actisorb Silver 220 Antimicrobial Binding DressingJohnson & Johnson Medical, Ltd.200312—
+2K230190Polyver Silver Alginate Dressing (Prescription and OTC)Roosin Medical Co., Ltd.20230—
+2K192478LT Antibacterial Alginate with Silver DressingZhejiang Longterm Medical Technology Co., Ltd.20200—
+2K140147BCT Antimicrobial Dressing & BCT Silver BandageBio-Medical Carbon Technology Co., Ltd.20140—
+2K120181Lufucon Silver Alginate Dressing 50X50MM, Lufucon Silver Alginate Dressing 100X100MM…Huizhou Foryou Medical Devices Co., Ltd.20136—
+2K082333Asap Wound Dressing GelAmerican Biotech Labs20096—
+2K090453Silver Alginate 11 Wound DressingAdvanced Medical Solutions Limited200903
+2K080503Silver Alginate IV Antimicrobial Wound DressingAdvanced Medical Solutions Limited20080—
+2K081363Non-Adherent Antimicrobial Alginate Dressing, Silvercel Non-Adherent Antimicrobial…Advanced Medical Solutions Limited20080—
+2K071442Suprasorb a +AGSpecialty Fibres and Materials, Ltd.200811
+2K063173Modification to Silver Alginate II Wound DressingAdvanced Medical Solutions Limited20063—
+2K050261V.a.C. Granufoam Silver Protection DressingKinetic Concepts, Inc.20057—
+2K033869Contreet Foam Cavity Dressing with Silver, Model 9628 (2X4 in.)Coloplast Corp.200417—
+2K032986Clo-Surplusp.a.D.Scion Cardio-Vascular, Inc.200425—
+2K032463Curad Silver BandageBeiersdorf AG20042—
+2K032462Curad Silver Active Gel BandageBeiersdorf AG20040—
+3K183208Suprasorb A + Ag “R”Speciality Fibres and Materials, Ltd.20190—
+3K172554LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial Alginate DressingHuizhou Foryou Medical Devices Co., Ltd.20183—
+3K161013InnoSEAL Hemostatic PadInnotherapy, Inc.20160—
+3K150916HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO…Hem Con Medical Technologies, Inc.20153—
+3K150963AnsCare ChitoClot PadBenq Materials Corporation20150—
+3K143335Roosin Silver Calcium Alginate Dressing (Prescription), Roosin Alginate Dressing with…Roosin Medical Devices Co., Ltd.20151—
+3K141033Silverlon Antimicrobial Wound Contact Negative Pressure Dressings, Silverlon Easy AG…Argentum Medical, LLC20140—
+3K140483Asap Otc Wound Dressing GelAbl Medical, LLC20141—
+3K131176Ross RU Skin DiscontinuitiesBiotd S.A.20141—
+3K123961Sentrex Biosponge MPDBionova Medical, Inc.20134—
+3K102944Coreleader Hemo-Pad Model Cpii 02030Coreleader Biotech Co., Ltd.20112—
+3K100580Exsalt Wound DressingExciton Technologies, Inc.20100—
+3K100218Biatain Agfoam Dressings-Non-Adhesiv: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CMColoplast A/S201011—
+3K092826Asap Antimicrobial Silver Wound Dressing GelAmerican Biotech Labs20092—
+3K082910CVS Silver Bandages, Walgreens Silver Bandages, Xyz Silver BandagesAso, LLC20090—
+3K090100Softseal-STFChitogen, Inc.20092—
+3K080818Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical DressingHem Con Medical Technologies, Inc.200811—
+3K070175Aquanova Super-Absorbent Gelling Dressing, OtcMedtrade Products, Ltd.20076—
+3K053627Modification to: V.a.C. Granufoam Silver Protection DressingKci USA, Inc.20065—
+4K254246LT Antibacterial Foam with Silver DressingZhejiang Longterm Medical Technology Co., Ltd.20260—
+4K212521Field Shield Wound DressingKericure, Inc.20240—
+4K212766Maxiocel Chitosan Wound DressingAdvamedica, Inc.20230—
+4K210949Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc.20223—
+4K220566Vascette HP (hemostatic pad)Koag, LLC20220—
+4K202982Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC…Winner Medical Co., Ltd.20211—
+4K202830Axiostat PatchAdvamedica, Inc.20210—
+4K201016LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Antibacterial Alginate Wound…Huizhou Foryou Medical Devices Co., Ltd.20210—
+4K191819Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing…Winner Medical Co., Ltd.20201—
+4K191536Biatain Silicone AgColoplast A/S20200—
+4K182811gel-e Flex+Gel-E, Inc.20191—
+4K173005SURECELL Gelling Fiber Wound DressingJiangsu Newvalue Medical Producst Co.,Ltd20180—
+4K162017Ross Ru Wound Dressing GelBiotd S.A.20170—
+4K150985Medihoney Wound GelDerma Sciences, Inc.201501
+4K151204HEMO-BandageCoreleader Biotech Co., Ltd.20150—
+4K140954Luofucon Silver PU Antibacterial Foam DressingHuizhou Foryou Medical Devices Co., Ltd.20155—
+4K143124KA01 Chitosan Wound DressingFoshan United Medical Technologies, Ltd.20152—
+4K112864Softseal-CChitogen, Inc.20120—
+4K120828Biatain Silicone AG Foam Dressing - Adhesive: 3X3 Inches, 4X4 Inches, & 5X5 InchesColoplast A/S20122—
+4K102956V.a.C. Granufoam Silver Small Dressing; V.a.C. Granufoam Silver Medium Dressing; V.a.C.…Kci USA, Inc. (Kinetic Concepts, Inc.)20100—
+4K100693Aquanova AG Super Absorbant Dressing, Aquanova AG Antimicrobial DressingMedtrade Products Limited20101—
+4K093519Medtrade Products Celox Vascular Topical Hemostatic Granules on SheetMedtrade Products, Ltd.20102—
+4K090620Quikclot Inteventional, Model P/N 182Z-Medica Corporation20095—
+4K062227V.a.C. Therapy SystemKci USA, Inc. (Kinetic Concepts, Inc.)200632
+5K223359LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam DressingHuizhou Foryou Medical Devices Co., Ltd.20230—
+5K231937Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc.20232—
+5K220673Sterile Silver Alginate Wound DressingQingdao Bright Moon Biomedical Materials Co., Ltd.20230—
+5K221754Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone Ag Foam…Winner Medical Co., Ltd.20230—
+5K190012OMNI-STAT Vascular (Rapid); CELOX Vascular RapidMedtrade Product, Ltd.20190—
+5K192667gel-e Flex+ gel OTCGel-E, Inc.20190—
+5K172155StatGuard Hemostatic Patch, StatGuard Hemostatic DressingStatguard, LLC20180—
+5K172010gel-e BandageGel-E, Inc. (Formerly Remedium Technologies, Inc.)20170—
+5K160022LUOFUCON Silicone Ag foam dressingHuizhou Foryou Medical Devices Co., Ltd.20163—
+5K121817Vcare aIVT Medical, Ltd.20130—
+5K120782Interventional Hemostatic BandageZ-Medica Corporation20131—
+5K102965Celox Trauma Gauze AG, Celox Hemostatic Antibacterial Trauma Gauze, Omni-Stat Trauma…Medtrade Products, Ltd.20100—
+5K083357Open Abdomen Negative Pressure Therapy System, Model 370502, Canister, Model 370510Kci USA, Inc.20091—
+6K243181Foundation Dermal Regeneration Scaffold Plus (DRS+) SoloBionova Medical, Inc.20240—
+6K240298Foundation Dermal Regeneration Scaffold Plus (DRS+) DuoBionova Medical, Inc.20241—
+6K181641QuikClot RadialZ-Medica, LLC20180—
+6K170077LUOFUCON Silicone Ag Foam Dressing with BorderHuizhou Foryou Medical Devices Co., Ltd.20172—
+6K120499Abthera Open Abdomen Negative Pressure Therapy SystemKci USA, Inc. (Kinetic Concepts, Inc.)20120—
+7K223360LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam DressingHuizhou Foryou Medical Devices Co., Ltd.20241—
+8K242856LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+…Huizhou Foryou Medical Devices Co., Ltd.20240—