510(k) Report

Devices descending from K970566

177 later devices reach Arglaes Film Dressing through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K041268Silversite or CalgitrolAdri20042—
+1K033587SilversealNoble Fiber Technologies20049—
+1K004028Arglaes-AB Antimicrobial Barrier Powder DressingMaersk Medical, Ltd.20010—
+1K990810Arglaes-AB Antimicrobial Barrier Film Dressing & Island DressingMaersk Medical, Ltd.199928—
+1K981299Silverlon Contact Wound DressingArgentum International, LLC1998149—
+2K173072Algidex Ag Silver Alginate Wound DressingDeroyal Industries, Inc.20180—
+2K153756Microlyte AgImbed Biosciences, Inc.20161—
+2K141033Silverlon Antimicrobial Wound Contact Negative Pressure Dressings, Silverlon Easy AG…Argentum Medical, LLC20140—
+2K133137Cisnap Closed Incision SystemSpiracur, Inc.20140—
+2K121819Surgiclear Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and SilverCovalontechnologies, Inc.20123—
+2K112549IV Clear Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and SilverCovalontechnologies, Inc.20120—
+2K102212D-Stat Dry Silver; D-Stat Dry Clear Silver; D-Stat Dry Wrap Silver; Thrombix SilverVascular Solutions, Inc.20110—
+2K083113Acticoat Flex 7 DressingSmith & Nephew, Inc.200922—
+2K073213Therabond Antimicrobial Barrier SystemsChoice Therapeutics20085—
+2K063190Silverseal Wound Packing Strips with X-StaticNoble Fiber Technologies, Inc.20070—
+2K984204Silverlon Direct Pressure Wound Closure StripArgentum International, LLC20070—
+2K050086Brennen Medical Silver Glucan Wound DressingBrennen Medical, Inc.20060—
+2K050726Silverseal Silveraid with X-StaticNoble Fiber Technologies, Inc.20052—
+2K050649Silverseal Contacting Wound Dressing with X-StaticNoble Fiber Technologies, Inc.20055—
+2K033900X-Static Silverseal Hydrocolloid Film and Island DressingNoble Fiber Technologies20052—
+2K040518Select Fabricators, Inc., Agmed Tex Wound DressingSelect Fabricators, Inc.20041—
+2K033453Kendall Ultec Pro AG+ Hydrocolloid DressingTyco Healthcare20040—
+2K024054Xylos Xcell Antimicrobial DressingXylos Corporation20037—
+2K023612Silverlon Contact Wound DressingArgentum International, LLC2003102—
+2K023609Silverlon Adhesive StripArgentum International, LLC200321—
+2K013525Contreet-H Antimicrobial Hydrocolloid Dressing, Models 9610 (4 X 4 (10 CM X 10CM), 9613…Coloplast Corp.200213—
+2K984210Silverlon Wound Packing StripsArgentum International, LLC199925—
+2K984208Silverlon Island Dressing, Silverlon Island PadArgentum International, LLC199914—
+3K211943Microlyte Ag/LidocaineImbed Biosciences20240—
+3K163529ReliaTect Post-Op Dressing with CHG (8cm x 15cm), ReliaTect Post-Op Dressing with CHG…Avery Dennison Corporation20171—
+3K153723ACTICOAT Surgical DressingSmith & Nephew Medical Limited20160—
+3K150256Silverlon Burn Contact DressingsArgentum Medical20154—
+3K140389Chloraderm Antimicrobial Transparent Thin Film Dressing, 2 3/8 X 2 3/4, 4 X 4 3/4Entrotech Life Sciences, Inc.20140—
+3K122817Silverlon Island Wound DressingArgentum Medical, LLC201413—
+3K123961Sentrex Biosponge MPDBionova Medical, Inc.20134—
+3K120181Lufucon Silver Alginate Dressing 50X50MM, Lufucon Silver Alginate Dressing 100X100MM…Huizhou Foryou Medical Devices Co., Ltd.20136—
+3K103793Durafiber AGSmith & Nephew, Inc.20111—
+3K100580Exsalt Wound DressingExciton Technologies, Inc.20100—
+3K093351Collawound ArtCollamatrix, Inc.20100—
+3K083133Silveri: Coflex Afd, Coflex Afd First Aid, Afd Pad Foam Dressing, Powerflex Afd Foam…Andover Healthcare, Inc.20093—
+3K082333Asap Wound Dressing GelAmerican Biotech Labs20096—
+3K072378Prowick Antimicrobial Postoperative Wound Dressing, Shoulder and Knee, Models AR-1625…Arthrex, Inc.20071—
+3K063069Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC200773—
+3K063063Silvacide Skin & Wound Moisturizing SolutionMedical Molecular Therapuetics, LLC200714—
+3K050842Agcel Wound Dressing,Agcel Burn DressingModern Medical Equipment Mfg., Ltd.20060—
+3K061220Urgotul AGLaboratoires Urgo20067—
+3K050032Euromed Sureskin Iii with Silver Wound DressingsEuromed, Inc.20062—
+3K051647Fortaderm Antimicrobial Wound DressingOrganogenesis, Inc.20053—
+3K051445Milliken Silver Wound DressingsMilliken Chemical20053—
+3K033869Contreet Foam Cavity Dressing with Silver, Model 9628 (2X4 in.)Coloplast Corp.200417—
+3K032463Curad Silver BandageBeiersdorf AG20042—
+3K032462Curad Silver Active Gel BandageBeiersdorf AG20040—
+4K251582Redermax Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.20261—
+4K251866Tegaderm Post-Op Transparent Antimicrobial DressingSolventum US, LLC20250—
+4K223360LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam DressingHuizhou Foryou Medical Devices Co., Ltd.20241—
+4K223359LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam DressingHuizhou Foryou Medical Devices Co., Ltd.20230—
+4K210949Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc.20223—
+4K190343Silverlon Wound Contact, Burn Contact DressingsArgentum Medical, LLC20193—
+4K172554LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial Alginate DressingHuizhou Foryou Medical Devices Co., Ltd.20183—
+4K161289DURAFIBER AgSmith & Nephew Medical Limited20160—
+4K151185AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser (Rx) and AGX Wound Wash…Abl Medical, LLC20160—
+4K151186Stay Fresh Hydrocolloid dressingSarasota Medical Products, Inc.20150—
+4K143335Roosin Silver Calcium Alginate Dressing (Prescription), Roosin Alginate Dressing with…Roosin Medical Devices Co., Ltd.20151—
+4K143001Silverlon Island Wound Dressing, Silverlon Wound Pad DressingArgentum Medical20145—
+4K141573Silverlon Island Wound DressingArgentum Medical20140—
+4K140483Asap Otc Wound Dressing GelAbl Medical, LLC20141—
+4K131176Ross RU Skin DiscontinuitiesBiotd S.A.20141—
+4K111313Exsept Skin and Wound Cleanser with Antimicrobial PreservativeAlcavis Hdc, LLC20119—
+4K103141Low Adherent Afm AG DressingsMilliken Healthcare Products, LLC20110—
+4K100429Urgocell AG, Antimicrobial Wound Dressing with SilverLaboratoires Urgo20100—
+4K100430Urgotul AG, Antimicrobial Wound Dressing with SilverLaboratoires Urgo20102—
+4K100218Biatain Agfoam Dressings-Non-Adhesiv: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CMColoplast A/S201011—
+4K093188Afm Ultra AG DressingsMilliken & Co.20101—
+4K093227Silverstream and DermaseptEnzysurge, Ltd.20091—
+4K092826Asap Antimicrobial Silver Wound Dressing GelAmerican Biotech Labs20092—
+4K082910CVS Silver Bandages, Walgreens Silver Bandages, Xyz Silver BandagesAso, LLC20090—
+4K082858Exsept WC Antimicrobial Skin and Wound CleanserAlcavis International, Inc.20090—
+4K083007ProwickArthrex, Inc.20090—
+4K083355Wound Wash Saline, 210 ML, Model B8552, Wound Wash Saline, 90 ML, Model B8553Blairex Laboratories, Inc.200813—
+4K081274Sureskin Silver BandagesEuromed, Inc.20081—
+4K073547Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound GelAnacapa Technologies, Inc.200866—
+4K062559Urgocell AG Antimicrobial Wound Dressing with SilverLaboratoires Urgo20076—
+5K254246LT Antibacterial Foam with Silver DressingZhejiang Longterm Medical Technology Co., Ltd.20260—
+5K261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.20260—
+5K242758Atrauman® AgHartmann USA, Inc.20240—
+5K242856LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+…Huizhou Foryou Medical Devices Co., Ltd.20240—
+5K212521Field Shield Wound DressingKericure, Inc.20240—
+5K230190Polyver Silver Alginate Dressing (Prescription and OTC)Roosin Medical Co., Ltd.20230—
+5K231937Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc.20232—
+5K221218Silverlon Wound Contact, Burn Contact DressingsArgentum Medical, Inc.20221—
+5K202982Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC…Winner Medical Co., Ltd.20211—
+5K201016LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Antibacterial Alginate Wound…Huizhou Foryou Medical Devices Co., Ltd.20210—
+5K200767SilverStream GelEnzysurge, Ltd.20200—
+5K191819Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing…Winner Medical Co., Ltd.20201—
+5K191536Biatain Silicone AgColoplast A/S20200—
+5K183662Saline Wound Wash, SteriCleanse (TM)Ascent Consumer Products, Inc.20190—
+5K180570Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon…Argentum Medical, LLC20191—
+5K180533Procellera Composite Antibacterial Wound DressingVomaris Wound Care, Inc.20180—
+5K180643MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs)Medcu Technologies, Ltd.20181—
+5K162017Ross Ru Wound Dressing GelBiotd S.A.20170—