510(k) Report

Devices descending from K984371

81 later devices reach Mepitel Non Adherent Silicone Dressing through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141847Avance Foam Dressing KitsMolnlycke Health Care Us, LLC201514—
+1K130040Mepitel AGMolnlycke Health Care20140—
+1K123961Sentrex Biosponge MPDBionova Medical, Inc.20134—
+1K063271Aquacel Hydrofiber Dressing and Aquacel AG with Hydrofiber Silver Impregnated…Convatec, A Division of E.R. Squibb & Sons, LLC200759—
+2K210949Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc.20223—
+2K170088Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze…Medela AG201781
+2K161935Avance Foam Dressing Kit - XLMolnlycke Health Care Us, LLC20160—
+2K161797Avance Tubing, Avance Y-Connector, Avance ViewPadMolnlycke Health Care Us, LLC20160—
+2K152741Mepiseal Soft Silicone SealantMolnlycke Health Care Us, LLC20160—
+2K151872Avance Y-Connector SMolnlycke Health Care Us, LLC20152—
+2K143017Urgoclean Ag, Antibacterial Absorbent Wound Dressing with SilverLaboratoires Urgo20150—
+2K143124KA01 Chitosan Wound DressingFoshan United Medical Technologies, Ltd.20152—
+2K123219Urgoclean Absorbent Wound DressingLaboratoires Urgo20130—
+2K081246TT-102Tissue Technologies Holdings, LLC20090—
+2K080383Aquacel Hydrofiber Wound Dressing and AG Hydrofiber DressingConvatec, A Division of E.R. Squibb & Sons, LLC200854—
+3K231937Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc.20232—
+3K212766Maxiocel Chitosan Wound DressingAdvamedica, Inc.20230—
+3K210466Silver Gelling Fiber DressingWinner Medical Co., Ltd.20221—
+3K183645Silver High Performance DressingAdvanced Medical Solutions, Ltd.201941
+3K182409Applied Tissue Technologies PWD™ Platform Wound DressingApplied Tissue Technologies, LLC20192—
+3K181204RENASYS Y-Connector; RENASYS TOUCHSmith & Nephew Medical Limited20190—
+3K180415Invia White Foam NPWTMedela AG20180—
+3K172145Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy…Medela AG20183—
+3K172010gel-e BandageGel-E, Inc. (Formerly Remedium Technologies, Inc.)20170—
+3K162508KerraCel Ag Gelling Fiber Silver DressingExciton Technologies, Inc.201711
+3K153756Microlyte AgImbed Biosciences, Inc.20161—
+3K122817Silverlon Island Wound DressingArgentum Medical, LLC201413—
+3K123481Aquacel AG Foam Hydrofiber Foam Dressing with Silver, Adhesive and Non AdhesiveConvatec, Inc.201301
+3K121275Aquacel AG Extra Hydrofiber Dressing with Silver and Strengthening FiberConvatec, Inc.201213—
+3K121522Polyfit Absorbing Antimicrobial Dressings (Otc)Polyremedy, Inc.20125—
+3K101257Advanced Trauma Dressing (Atd)Nanosys, Inc.20110—
+3K103793Durafiber AGSmith & Nephew, Inc.20111—
+3K100693Aquanova AG Super Absorbant Dressing, Aquanova AG Antimicrobial DressingMedtrade Products Limited20101—
+3K091034Aquacel AG SurgicalConvatec20092—
+3K090254Silver Impregnated Hydrofiber Dressing Reinforced with Nylon (Flat)Convatec, A Division of E.R. Squibb & Sons, LLC20091—
+4K254019Wound Geni NPWT SystemBechtel Medical, Inc.20260—
+4K243181Foundation Dermal Regeneration Scaffold Plus (DRS+) SoloBionova Medical, Inc.20240—
+4K222740Venus Ag 120, 160, 200 2x2 inch, Venus Ag 120, 160, 200 4x4 inch, Venus Ag 120, 160, 200…Speciality Fibres and Materials, Ltd.20240—
+4K211943Microlyte Ag/LidocaineImbed Biosciences20240—
+4K240298Foundation Dermal Regeneration Scaffold Plus (DRS+) DuoBionova Medical, Inc.20241—
+4K223388Invia® Integrated DressingMedela AG20230—
+4K221532PHMB Wound DressingWinner Medical Co., Ltd.20230—
+4K221720Extra Silver Gelling Fiber DressingWinner Medical Co., Ltd.20220—
+4K214112Invia Ease Negative Pressure Wound Therapy (NPWT) SystemMedela AG20220—
+4K210718LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling…Huizhou Foryou Medical Devices Co., Ltd.20222—
+4K210974High Performance Antimicrobial Gelling Fiber with SilverAdvanced Medical Solutions, Ltd.20210—
+4K191460PWD Platform Wound Dressing 3” x 5” OblongApplied Tissue Technologies, LLC20191—
+4K173844Titan Ag 200Specialty Fibres and Materials, Ltd.20181—
+4K180634Surgical Silver Post Operative DressingAdvanced Medical Solutions, Ltd.20180—
+4K173675AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening FiberConvatec Limited20184—
+4K172570ALGS6 Ag Alginate Wound DressingFoshan United Medical Technologies, Ltd.20182—
+4K160379Exufiber Ag+Molnlycke Health Care Us, LLC20160—
+4K161289DURAFIBER AgSmith & Nephew Medical Limited20160—
+4K152926AQUACEL Ag Surgical SP DressingConvatec Limited201601
+4K150256Silverlon Burn Contact DressingsArgentum Medical20154—
+4K143001Silverlon Island Wound Dressing, Silverlon Wound Pad DressingArgentum Medical20145—
+4K141033Silverlon Antimicrobial Wound Contact Negative Pressure Dressings, Silverlon Easy AG…Argentum Medical, LLC20140—
+4K141573Silverlon Island Wound DressingArgentum Medical20140—
+4K130857Prontosan Wound Gel XB.Braun Medical, Inc.20133—
+4K102212D-Stat Dry Silver; D-Stat Dry Clear Silver; D-Stat Dry Wrap Silver; Thrombix SilverVascular Solutions, Inc.20110—
+4K102965Celox Trauma Gauze AG, Celox Hemostatic Antibacterial Trauma Gauze, Omni-Stat Trauma…Medtrade Products, Ltd.20100—
+5K252167Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber…Qingdao Bright Moon Biomedical Materials Co., Ltd.20250—
+5K240485LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription use),LUOFUCON® Silver…Huizhou Foryou Medical Devices Co., Ltd.20240—
+5K233111ALGS2 Ag Alginate Wound Dressing Rx; ALGS2 Ag Alginate Wound Dressing OTC; ALGS2S…Foshan United Medical Technologies, Ltd.20240—
+5K231953Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in); Biatain Fiber Ag (33572 - 10 cm x…Coloplast Corp.20240—
+5K221110LUOFUCON Silver Gelling Fiber Surgical Dressing, LUOFUCON Antibacterial Gelling Fiber…Huizhou Foryou Medical Devices Co., Ltd.20240—
+5K213473Antimicrobial Gelling Fiber Dressing with PHMBAdvanced Medical Solutions, Ltd.20230—
+5K223259coactiv+™ Antimicrobial Wound GelKane Biotech, Inc.20231—
+5K212359PWD Negative Pressure Wound Therapy SystemApplied Tissue Technologies, LLC20220—
+5K192478LT Antibacterial Alginate with Silver DressingZhejiang Longterm Medical Technology Co., Ltd.20200—
+5K192527Rochal Antimicrobial Wound GelRochal Industries, LLC20202—
+5K190343Silverlon Wound Contact, Burn Contact DressingsArgentum Medical, LLC20193—
+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—
+6K241809coactiv+™ Antimicrobial Wound GelKane Biotech, Inc.20240—
+6K212521Field Shield Wound DressingKericure, Inc.20240—
+6K231088Copper Foam Dressing (Prescription and OTC)Roosin Medical Co., Ltd.20240—
+6K221754Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone Ag Foam…Winner Medical Co., Ltd.20230—
+6K221218Silverlon Wound Contact, Burn Contact DressingsArgentum Medical, Inc.20221—
+7K241225Silverlon® Wound Contact, Burn Contact DressingArgentum Medical, LLC20240—