510(k) Report

Devices descending from K935096

18 later devices reach Biolex Impregnated Wound Dressing through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K053538Modification to Phytacare Alginate Hydrogel Wound FillerCurapharm, Inc.200615—
+1K981150Solosite Gel Conformable DressingSmith & Nephew, Inc.19981—
+2K122297Enluxtra Humifiber Wound DressingBasf Venture Capital America, Inc.20120—
+2K081584Derma Sciences Otc Medihoney Dressings with Active Manuka HoneyDerma Sciences, Inc.200814—
+3K101114Advancis Activon TubeAdvancis Medical20110—
+3K101793Medihoney Gel Dressing with Active Manuka HoneyDerma Sciences, Inc.201124
+3K102659Manukahd, Manukahd Rope, Manukahd BorderManuka Medical Limited20103—
+3K092689Manukapli Wound DressingManuka Medical Limited201010—
+4K150676L-Mesitran Dressing Family II- Soft and TulleTheo Manufacturing BV20150—
+4K150985Medihoney Wound GelDerma Sciences, Inc.201501
+4K121227Manuka FillLinks Medical Products, Inc.20124—
+4K110042ManukatexManuka Medical Limited20112—
+5K131796Manuka Fill Wound DressingLinks Medical Products, Inc.201431
+5K120976Manuka IGLinks Medical Products, Inc.20121—
+6K173911Medline Burn and Wound DressingMedline Industries, Inc.20182—
+6K133934Manuka Foam HC, Manuka Foam HC (with Acrylic Adhesive Border), Manuka Foam HC (with…Links Medical Products, Inc.20140—
+7K254191IWD-Gel™InnovaCorium, Inc.20260—
+7K190224Medline Burn and Wound Dressing (OTC)Medline Industries, Inc.20190—