510(k) Report

Devices descending from K941263

15 later devices reach Comfeel Plus Wound Dressing through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K013525Contreet-H Antimicrobial Hydrocolloid Dressing, Models 9610 (4 X 4 (10 CM X 10CM), 9613…Coloplast Corp.200213—
+1K955863Alldress Multi Layered Wound DressingMolnlycke/Scott Health Care19960—
+2K061220Urgotul AGLaboratoires Urgo20067—
+2K050032Euromed Sureskin Iii with Silver Wound DressingsEuromed, Inc.20062—
+2K033900X-Static Silverseal Hydrocolloid Film and Island DressingNoble Fiber Technologies20052—
+2K033453Kendall Ultec Pro AG+ Hydrocolloid DressingTyco Healthcare20040—
+3K151186Stay Fresh Hydrocolloid dressingSarasota Medical Products, Inc.20150—
+3K100429Urgocell AG, Antimicrobial Wound Dressing with SilverLaboratoires Urgo20100—
+3K100430Urgotul AG, Antimicrobial Wound Dressing with SilverLaboratoires Urgo20102—
+3K081274Sureskin Silver BandagesEuromed, Inc.20081—
+3K072378Prowick Antimicrobial Postoperative Wound Dressing, Shoulder and Knee, Models AR-1625…Arthrex, Inc.20071—
+3K062559Urgocell AG Antimicrobial Wound Dressing with SilverLaboratoires Urgo20076—
+4K242758Atrauman® AgHartmann USA, Inc.20240—
+4K130040Mepitel AGMolnlycke Health Care20140—
+4K083007ProwickArthrex, Inc.20090—