510(k) Report

Devices descending from K982116

60 later devices reach Aquacel Hydrofiber Wound Dressing through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123219Urgoclean Absorbent Wound DressingLaboratoires Urgo20130—
+1K080383Aquacel Hydrofiber Wound Dressing and AG Hydrofiber DressingConvatec, A Division of E.R. Squibb & Sons, LLC200854—
+1K070175Aquanova Super-Absorbent Gelling Dressing, OtcMedtrade Products, Ltd.20076—
+2K212766Maxiocel Chitosan Wound DressingAdvamedica, Inc.20230—
+2K210466Silver Gelling Fiber DressingWinner Medical Co., Ltd.20221—
+2K183645Silver High Performance DressingAdvanced Medical Solutions, Ltd.201941
+2K173005SURECELL Gelling Fiber Wound DressingJiangsu Newvalue Medical Producst Co.,Ltd20180—
+2K162508KerraCel Ag Gelling Fiber Silver DressingExciton Technologies, Inc.201711
+2K153756Microlyte AgImbed Biosciences, Inc.20161—
+2K143017Urgoclean Ag, Antibacterial Absorbent Wound Dressing with SilverLaboratoires Urgo20150—
+2K143124KA01 Chitosan Wound DressingFoshan United Medical Technologies, Ltd.20152—
+2K122817Silverlon Island Wound DressingArgentum Medical, LLC201413—
+2K123481Aquacel AG Foam Hydrofiber Foam Dressing with Silver, Adhesive and Non AdhesiveConvatec, Inc.201301
+2K121275Aquacel AG Extra Hydrofiber Dressing with Silver and Strengthening FiberConvatec, Inc.201213—
+2K121522Polyfit Absorbing Antimicrobial Dressings (Otc)Polyremedy, Inc.20125—
+2K101257Advanced Trauma Dressing (Atd)Nanosys, Inc.20110—
+2K103793Durafiber AGSmith & Nephew, Inc.20111—
+2K100693Aquanova AG Super Absorbant Dressing, Aquanova AG Antimicrobial DressingMedtrade Products Limited20101—
+2K091034Aquacel AG SurgicalConvatec20092—
+2K090254Silver Impregnated Hydrofiber Dressing Reinforced with Nylon (Flat)Convatec, A Division of E.R. Squibb & Sons, LLC20091—
+3K222740Venus Ag 120, 160, 200 2x2 inch, Venus Ag 120, 160, 200 4x4 inch, Venus Ag 120, 160, 200…Speciality Fibres and Materials, Ltd.20240—
+3K211943Microlyte Ag/LidocaineImbed Biosciences20240—
+3K221532PHMB Wound DressingWinner Medical Co., Ltd.20230—
+3K221720Extra Silver Gelling Fiber DressingWinner Medical Co., Ltd.20220—
+3K210718LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling…Huizhou Foryou Medical Devices Co., Ltd.20222—
+3K210974High Performance Antimicrobial Gelling Fiber with SilverAdvanced Medical Solutions, Ltd.20210—
+3K173844Titan Ag 200Specialty Fibres and Materials, Ltd.20181—
+3K180634Surgical Silver Post Operative DressingAdvanced Medical Solutions, Ltd.20180—
+3K173675AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening FiberConvatec Limited20184—
+3K172570ALGS6 Ag Alginate Wound DressingFoshan United Medical Technologies, Ltd.20182—
+3K172010gel-e BandageGel-E, Inc. (Formerly Remedium Technologies, Inc.)20170—
+3K160379Exufiber Ag+Molnlycke Health Care Us, LLC20160—
+3K161289DURAFIBER AgSmith & Nephew Medical Limited20160—
+3K152926AQUACEL Ag Surgical SP DressingConvatec Limited201601
+3K150256Silverlon Burn Contact DressingsArgentum Medical20154—
+3K143001Silverlon Island Wound Dressing, Silverlon Wound Pad DressingArgentum Medical20145—
+3K141033Silverlon Antimicrobial Wound Contact Negative Pressure Dressings, Silverlon Easy AG…Argentum Medical, LLC20140—
+3K141573Silverlon Island Wound DressingArgentum Medical20140—
+3K130857Prontosan Wound Gel XB.Braun Medical, Inc.20133—
+3K102212D-Stat Dry Silver; D-Stat Dry Clear Silver; D-Stat Dry Wrap Silver; Thrombix SilverVascular Solutions, Inc.20110—
+3K102965Celox Trauma Gauze AG, Celox Hemostatic Antibacterial Trauma Gauze, Omni-Stat Trauma…Medtrade Products, Ltd.20100—
+4K252167Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber…Qingdao Bright Moon Biomedical Materials Co., Ltd.20250—
+4K240485LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription use),LUOFUCON® Silver…Huizhou Foryou Medical Devices Co., Ltd.20240—
+4K233111ALGS2 Ag Alginate Wound Dressing Rx; ALGS2 Ag Alginate Wound Dressing OTC; ALGS2S…Foshan United Medical Technologies, Ltd.20240—
+4K231953Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in); Biatain Fiber Ag (33572 - 10 cm x…Coloplast Corp.20240—
+4K221110LUOFUCON Silver Gelling Fiber Surgical Dressing, LUOFUCON Antibacterial Gelling Fiber…Huizhou Foryou Medical Devices Co., Ltd.20240—
+4K213473Antimicrobial Gelling Fiber Dressing with PHMBAdvanced Medical Solutions, Ltd.20230—
+4K223259coactiv+™ Antimicrobial Wound GelKane Biotech, Inc.20231—
+4K192478LT Antibacterial Alginate with Silver DressingZhejiang Longterm Medical Technology Co., Ltd.20200—
+4K192527Rochal Antimicrobial Wound GelRochal Industries, LLC20202—
+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—
+5K241809coactiv+™ Antimicrobial Wound GelKane Biotech, Inc.20240—
+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—
+6K241225Silverlon® Wound Contact, Burn Contact DressingArgentum Medical, LLC20240—