510(k) Report

Devices descending from K080010

21 later devices reach Nocc Hydrophilic Wound Dressing through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112191Healex Biosponge Wound DressingBionova Medical, Inc.20125—
+1K081584Derma Sciences Otc Medihoney Dressings with Active Manuka HoneyDerma Sciences, Inc.200814—
+2K123961Sentrex Biosponge MPDBionova Medical, Inc.20134—
+2K101114Advancis Activon TubeAdvancis Medical20110—
+2K101793Medihoney Gel Dressing with Active Manuka HoneyDerma Sciences, Inc.201124
+2K102659Manukahd, Manukahd Rope, Manukahd BorderManuka Medical Limited20103—
+2K092689Manukapli Wound DressingManuka Medical Limited201010—
+3K210949Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc.20223—
+3K150676L-Mesitran Dressing Family II- Soft and TulleTheo Manufacturing BV20150—
+3K150985Medihoney Wound GelDerma Sciences, Inc.201501
+3K121227Manuka FillLinks Medical Products, Inc.20124—
+3K110042ManukatexManuka Medical Limited20112—
+4K231937Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc.20232—
+4K131796Manuka Fill Wound DressingLinks Medical Products, Inc.201431
+4K120976Manuka IGLinks Medical Products, Inc.20121—
+5K243181Foundation Dermal Regeneration Scaffold Plus (DRS+) SoloBionova Medical, Inc.20240—
+5K240298Foundation Dermal Regeneration Scaffold Plus (DRS+) DuoBionova Medical, Inc.20241—
+5K173911Medline Burn and Wound DressingMedline Industries, Inc.20182—
+5K133934Manuka Foam HC, Manuka Foam HC (with Acrylic Adhesive Border), Manuka Foam HC (with…Links Medical Products, Inc.20140—
+6K254191IWD-Gel™InnovaCorium, Inc.20260—
+6K190224Medline Burn and Wound Dressing (OTC)Medline Industries, Inc.20190—