510(k) Report

Devices descending from K001519

70 later devices reach Acticoat 7 Dressing through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083870Exsalt SD7 Wound DressingExciton Technologies, Inc.200912—
+1K083113Acticoat Flex 7 DressingSmith & Nephew, Inc.200922—
+1K061220Urgotul AGLaboratoires Urgo20067—
+1K051542Triosyn T40 Antimicrobial Wound DressingTriosyn Corp.20066—
+1K050086Brennen Medical Silver Glucan Wound DressingBrennen Medical, Inc.20060—
+1K051445Milliken Silver Wound DressingsMilliken Chemical20053—
+1K041642V.a.C. Granufoam Silver DressingKinetic Concepts, Inc.20058—
+1K033900X-Static Silverseal Hydrocolloid Film and Island DressingNoble Fiber Technologies20052—
+1K013525Contreet-H Antimicrobial Hydrocolloid Dressing, Models 9610 (4 X 4 (10 CM X 10CM), 9613…Coloplast Corp.200213—
+2K153723ACTICOAT Surgical DressingSmith & Nephew Medical Limited20160—
+2K141033Silverlon Antimicrobial Wound Contact Negative Pressure Dressings, Silverlon Easy AG…Argentum Medical, LLC20140—
+2K122817Silverlon Island Wound DressingArgentum Medical, LLC201413—
+2K123961Sentrex Biosponge MPDBionova Medical, Inc.20134—
+2K113564Exsalt T7 Wound DressingExciton Technologies, Inc.20111—
+2K103067Exsalt SD7 Wound DressingExciton Technologies, Inc.20113—
+2K103793Durafiber AGSmith & Nephew, Inc.20111—
+2K103141Low Adherent Afm AG DressingsMilliken Healthcare Products, LLC20110—
+2K100261Primatrix AG Antimicrobial Dermal Dermal Repair ScaffoldTei Biosciences, Inc.201063
+2K100580Exsalt Wound DressingExciton Technologies, Inc.20100—
+2K093320Dryodine Cadexomer-Iodine GelCollegium Pharmaceutical Incorporated20100—
+2K100429Urgocell AG, Antimicrobial Wound Dressing with SilverLaboratoires Urgo20100—
+2K100430Urgotul AG, Antimicrobial Wound Dressing with SilverLaboratoires Urgo20102—
+2K093188Afm Ultra AG DressingsMilliken & Co.20101—
+2K072378Prowick Antimicrobial Postoperative Wound Dressing, Shoulder and Knee, Models AR-1625…Arthrex, Inc.20071—
+2K063059Sorbact Wound DressingAbigo Medical AB20074—
+2K062559Urgocell AG Antimicrobial Wound Dressing with SilverLaboratoires Urgo20076—
+2K050032Euromed Sureskin Iii with Silver Wound DressingsEuromed, Inc.20062—
+2K050261V.a.C. Granufoam Silver Protection DressingKinetic Concepts, Inc.20057—
+2K033453Kendall Ultec Pro AG+ Hydrocolloid DressingTyco Healthcare20040—
+3K242758Atrauman® AgHartmann USA, Inc.20240—
+3K210949Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc.20223—
+3K182680KerraContact Ag Perf Advanced Perforated Silver Wound DressingExciton Technologies, Inc.20180—
+3K172318Endoform Silver Dermal TemplateAroa Biosurgery20170—
+3K171225Sorbact Wound Dressing-Ribbon GauzeAbigo Medical AB20170—
+3K161289DURAFIBER AgSmith & Nephew Medical Limited20160—
+3K153674Sorbact Foam Gentle Border, Sorbact SuperabsorbentAbigo Medical AB20160—
+3K151186Stay Fresh Hydrocolloid dressingSarasota Medical Products, Inc.20150—
+3K150256Silverlon Burn Contact DressingsArgentum Medical20154—
+3K143151Cutimed Sorbact Wound Dressings (Cutimed Sorbact Hydroactive, Cutimed Sorbact…Bsn Medical GmbH20151—
+3K143001Silverlon Island Wound Dressing, Silverlon Wound Pad DressingArgentum Medical20145—
+3K141603Ultra Silver DressingsMilliken Healthcare Products, LLC20140—
+3K141573Silverlon Island Wound DressingArgentum Medical20140—
+3K133775Exsalt SD7 Wound Dressing with Adhesive BackingExciton Technologies, Inc.20140—
+3K130040Mepitel AGMolnlycke Health Care20140—
+3K120605Permacol Surgical ImplantCovidien, LLC20124—
+3K100591SorbactAbigo Medical AB20110—
+3K083007ProwickArthrex, Inc.20090—
+3K081274Sureskin Silver BandagesEuromed, Inc.20081—
+3K053627Modification to: V.a.C. Granufoam Silver Protection DressingKci USA, Inc.20065—
+4K231937Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc.20232—
+4K190343Silverlon Wound Contact, Burn Contact DressingsArgentum Medical, LLC20193—
+4K180570Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon…Argentum Medical, LLC20191—
+4K180533Procellera Composite Antibacterial Wound DressingVomaris Wound Care, Inc.20180—
+4K180643MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs)Medcu Technologies, Ltd.20181—
+4K160181Colorado Therapeutics Xenograft ImplantColorado Therapeutics, LLC20161—
+4K133011Diaphragmatic Hernia GraftCook Biotech, Inc.201411
+4K102956V.a.C. Granufoam Silver Small Dressing; V.a.C. Granufoam Silver Medium Dressing; V.a.C.…Kci USA, Inc. (Kinetic Concepts, Inc.)20100—
+4K062227V.a.C. Therapy SystemKci USA, Inc. (Kinetic Concepts, Inc.)200632
+5K243181Foundation Dermal Regeneration Scaffold Plus (DRS+) SoloBionova Medical, Inc.20240—
+5K240298Foundation Dermal Regeneration Scaffold Plus (DRS+) DuoBionova Medical, Inc.20241—
+5K212521Field Shield Wound DressingKericure, Inc.20240—
+5K231088Copper Foam Dressing (Prescription and OTC)Roosin Medical Co., Ltd.20240—
+5K221754Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone Ag Foam…Winner Medical Co., Ltd.20230—
+5K221218Silverlon Wound Contact, Burn Contact DressingsArgentum Medical, Inc.20221—
+5K171817Biodesign Diaphragmatic Hernia GraftCook Biotech Incorporated20180—
+5K172937Colorado Therapeutics Xenograft ImplantColorado Therapeutics, LLC20170—
+5K121817Vcare aIVT Medical, Ltd.20130—
+5K083357Open Abdomen Negative Pressure Therapy System, Model 370502, Canister, Model 370510Kci USA, Inc.20091—
+6K241225Silverlon® Wound Contact, Burn Contact DressingArgentum Medical, LLC20240—
+6K120499Abthera Open Abdomen Negative Pressure Therapy SystemKci USA, Inc. (Kinetic Concepts, Inc.)20120—