510(k) Report

Devices descending from K973657

43 later devices reach Arglaes-AB Antimicrobial Barrier Island Dressing through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K004028Arglaes-AB Antimicrobial Barrier Powder DressingMaersk Medical, Ltd.20010—
+1K990530Kerlix MD Antimicrobial Gauze DressingThe Kendall Company, L.P.2000217
+1K990810Arglaes-AB Antimicrobial Barrier Film Dressing & Island DressingMaersk Medical, Ltd.199928—
+2K142962PROTOCOL Incision DressingDeroyal Industries20150—
+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—
+2K070653Kendall Kerlix Antimicrobial Super Sponge Dressing for Otc Use, Model 6662Tyco Healthcare20077—
+2K053476AllwoundAt Squared, LLC20061—
+2K033900X-Static Silverseal Hydrocolloid Film and Island DressingNoble Fiber Technologies20052—
+2K041268Silversite or CalgitrolAdri20042—
+2K033453Kendall Ultec Pro AG+ Hydrocolloid DressingTyco Healthcare20040—
+2K024054Xylos Xcell Antimicrobial DressingXylos Corporation20037—
+2K013525Contreet-H Antimicrobial Hydrocolloid Dressing, Models 9610 (4 X 4 (10 CM X 10CM), 9613…Coloplast Corp.200213—
+2K011941Excilon Amd Antimicrobial Sponge Model #7088The Kendall Company20011—
+3K211943Microlyte Ag/LidocaineImbed Biosciences20240—
+3K221755Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial…Winner Medical Co., Ltd.20230—
+3K173072Algidex Ag Silver Alginate Wound DressingDeroyal Industries, Inc.20180—
+3K163529ReliaTect Post-Op Dressing with CHG (8cm x 15cm), ReliaTect Post-Op Dressing with CHG…Avery Dennison Corporation20171—
+3K140389Chloraderm Antimicrobial Transparent Thin Film Dressing, 2 3/8 X 2 3/4, 4 X 4 3/4Entrotech Life Sciences, Inc.20140—
+3K121522Polyfit Absorbing Antimicrobial Dressings (Otc)Polyremedy, Inc.20125—
+3K102212D-Stat Dry Silver; D-Stat Dry Clear Silver; D-Stat Dry Wrap Silver; Thrombix SilverVascular Solutions, Inc.20110—
+3K093351Collawound ArtCollamatrix, Inc.20100—
+3K072378Prowick Antimicrobial Postoperative Wound Dressing, Shoulder and Knee, Models AR-1625…Arthrex, Inc.20071—
+3K070685Kendall Antimicrobial Drain Dressing for Otc Use, Model 6662Tyco Healthcare20070—
+3K061220Urgotul AGLaboratoires Urgo20067—
+3K050032Euromed Sureskin Iii with Silver Wound DressingsEuromed, Inc.20062—
+3K051647Fortaderm Antimicrobial Wound DressingOrganogenesis, Inc.20053—
+4K251582Redermax Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.20261—
+4K251866Tegaderm Post-Op Transparent Antimicrobial DressingSolventum US, LLC20250—
+4K221532PHMB Wound DressingWinner Medical Co., Ltd.20230—
+4K151186Stay Fresh Hydrocolloid dressingSarasota Medical Products, Inc.20150—
+4K130857Prontosan Wound Gel XB.Braun Medical, Inc.20133—
+4K100429Urgocell AG, Antimicrobial Wound Dressing with SilverLaboratoires Urgo20100—
+4K100430Urgotul AG, Antimicrobial Wound Dressing with SilverLaboratoires Urgo20102—
+4K083007ProwickArthrex, Inc.20090—
+4K081274Sureskin Silver BandagesEuromed, Inc.20081—
+4K062559Urgocell AG Antimicrobial Wound Dressing with SilverLaboratoires Urgo20076—
+5K261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.20260—
+5K242758Atrauman® AgHartmann USA, Inc.20240—
+5K223259coactiv+™ Antimicrobial Wound GelKane Biotech, Inc.20231—
+5K192527Rochal Antimicrobial Wound GelRochal Industries, LLC20202—
+5K130040Mepitel AGMolnlycke Health Care20140—
+6K241809coactiv+™ Antimicrobial Wound GelKane Biotech, Inc.20240—