510(k) Report

Devices descending from K010447

33 later devices reach Modification to Acticoat Foam Dressing through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K022416Contreet Foam Adhesive/Non-AdhesiveColoplast Corp.200332—
+2K100218Biatain Agfoam Dressings-Non-Adhesiv: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CMColoplast A/S201011—
+2K093188Afm Ultra AG DressingsMilliken & Co.20101—
+2K060832Retro-Tech DressingRetro-Tech, LLC20072—
+2K062559Urgocell AG Antimicrobial Wound Dressing with SilverLaboratoires Urgo20076—
+2K033164Abram's Multi-Density Polyurethane Foam Wound Dressing SystemDr. Len'S Medical Products, LLC20040—
+2K032742Silver Foam Wound DressingAdvanced Medical Solutions, Ltd.20043—
+2K033869Contreet Foam Cavity Dressing with Silver, Model 9628 (2X4 in.)Coloplast Corp.200417—
+3K254246LT Antibacterial Foam with Silver DressingZhejiang Longterm Medical Technology Co., Ltd.20260—
+3K191819Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing…Winner Medical Co., Ltd.20201—
+3K191536Biatain Silicone AgColoplast A/S20200—
+3K140954Luofucon Silver PU Antibacterial Foam DressingHuizhou Foryou Medical Devices Co., Ltd.20155—
+3K141603Ultra Silver DressingsMilliken Healthcare Products, LLC20140—
+3K130670Hydrofera Blue PU Bacteriostatic DressingHydrofera, LLC20141—
+3K123961Sentrex Biosponge MPDBionova Medical, Inc.20134—
+3K120828Biatain Silicone AG Foam Dressing - Adhesive: 3X3 Inches, 4X4 Inches, & 5X5 InchesColoplast A/S20122—
+3K100429Urgocell AG, Antimicrobial Wound Dressing with SilverLaboratoires Urgo20100—
+3K100430Urgotul AG, Antimicrobial Wound Dressing with SilverLaboratoires Urgo20102—
+3K072378Prowick Antimicrobial Postoperative Wound Dressing, Shoulder and Knee, Models AR-1625…Arthrex, Inc.20071—
+4K242758Atrauman® AgHartmann USA, Inc.20240—
+4K223359LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam DressingHuizhou Foryou Medical Devices Co., Ltd.20230—
+4K221754Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone Ag Foam…Winner Medical Co., Ltd.20230—
+4K210949Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc.20223—
+4K190268Hydrofera Blue READY - BorderHydrofera, LLC20190—
+4K160022LUOFUCON Silicone Ag foam dressingHuizhou Foryou Medical Devices Co., Ltd.20163—
+4K130040Mepitel AGMolnlycke Health Care20140—
+4K083007ProwickArthrex, Inc.20090—
+5K231937Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc.20232—
+5K170077LUOFUCON Silicone Ag Foam Dressing with BorderHuizhou Foryou Medical Devices Co., Ltd.20172—
+6K243181Foundation Dermal Regeneration Scaffold Plus (DRS+) SoloBionova Medical, Inc.20240—
+6K240298Foundation Dermal Regeneration Scaffold Plus (DRS+) DuoBionova Medical, Inc.20241—
+6K223360LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam DressingHuizhou Foryou Medical Devices Co., Ltd.20241—
+7K242856LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+…Huizhou Foryou Medical Devices Co., Ltd.20240—