510(k) Report

Devices descending from K984264

23 later devices reach Modification of Bionect Clear Hydrogel through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172338Catasyn Advanced Technology Wound HydrogelSynedgen, Inc.20180—
+1K080010Nocc Hydrophilic Wound DressingKytogenics, Inc.200821—
+2K112191Healex Biosponge Wound DressingBionova Medical, Inc.20125—
+2K081584Derma Sciences Otc Medihoney Dressings with Active Manuka HoneyDerma Sciences, Inc.200814—
+3K123961Sentrex Biosponge MPDBionova Medical, Inc.20134—
+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—
+4K210949Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc.20223—
+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—
+5K231937Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc.20232—
+5K131796Manuka Fill Wound DressingLinks Medical Products, Inc.201431
+5K120976Manuka IGLinks Medical Products, Inc.20121—
+6K243181Foundation Dermal Regeneration Scaffold Plus (DRS+) SoloBionova Medical, Inc.20240—
+6K240298Foundation Dermal Regeneration Scaffold Plus (DRS+) DuoBionova Medical, Inc.20241—
+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—