510(k) Report

Devices descending from K982731

49 later devices reach Merogel Nasal Dressing and Sinus Stent through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160101SinuBandBioinspire Technologies, Incorporated20160—
+1K122494Posisep and Posisep X Hemostat Dressing/Intranasal SplintHemostasis, LLC20132—
+1K070496Advacoat Sinus Gel and StentCarbylan Biosurgery20073—
+1K063308Advacoat Sinus Gel, Model 9100, Adva Sinus Stent, Model 9200Carbylan Biosurgery20064—
+1K052099Nasopore Nasal Dressing, Model Ndox-Yyy/ZZPolyganics B.V.,200517—
+1K012532Sepragel SinusGenzyme Corp.200147—
+1K993362HylasineBiomatrix, Inc.200035—
+2K202623Novapak Nasal Sinus Packing and StentMedtronic Xomed20200—
+2K181696ChitoZolveGyrus Acmi, Inc.20180—
+2K141816HemoporePolyganics B.V.,20140—
+2K141423Nasopore-FDPolyganics B.V.,20140—
+2K140992Arthrocare Nasastent CMC Nasal DressingArthroCare Corporation20140—
+2K113585Nasal/Epistaxis PackCogent Therapeutics, LLC20127—
+2K092401Sinexus Sinus Stent Gen 2, Model 1999-25Sinexus, Inc.20091—
+2K082276Synthemed DeviceSynthemed, Inc.20083—
+2K070715Nasopore EarPolyganics B.V.,2007113
+2K062540Nasopore Ear, Models ND04, ND05Polyganics B.V.,20060—
+2K043035Sepragel Ent Bioresorbable Packing/StentGenzyme Corporation200510—
+2K033666HemadermMedafor, Inc.200329—
+3K210411PosiSep EAR Fragmentable Ear DressingHemostasis, LLC20220—
+3K170913Composite Removable Sinus Stent SystemSts Medical20170—
+3K141704Novashield Injectable Nasal Packing and StentMedtronic, Inc.20142—
+3K122886Nexstat Plus and Nexfoam Plus Topical Hemostat DressingHemostasis, LLC20120—
+3K102459Nexstat (TM) Topical Hemostat Powder; Nexfoam (R) Topical SpongeHemostasis, LLC20109—
+3K080818Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical DressingHem Con Medical Technologies, Inc.200811—
+3K070886Merogel Injectable Bioresorbable StentMedtronic, Inc.20071—
+3K070211Traumarrest and Bleedarrest Hemostatic Particles and FoamHemostasis, LLC200728—
+4K172179Chitogel Endoscopic Sinus Surgery KitChitogel, Ltd.20171—
+4K150916HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO…Hem Con Medical Technologies, Inc.20153—
+4K151204HEMO-BandageCoreleader Biotech Co., Ltd.20150—
+4K140313Stopsbleeding Topical Hemostat Powder and FoamCoag Medical, LLC20141—
+4K132105Perclot TopicalCryolife, Inc.20140—
+4K122434Merogel Injectable Bioresorbable Nasal Dressing and Sinus Stent and Otologic GelMedtronic Xomed20120—
+4K120958Posisep and Posisep X Hemostat DressingsHemostasis, LLC20126—
+4K102742Nasal CeaseCatalina, Inc.20111—
+4K093519Medtrade Products Celox Vascular Topical Hemostatic Granules on SheetMedtrade Products, Ltd.20102—
+4K090620Quikclot Inteventional, Model P/N 182Z-Medica Corporation20095—
+4K082601UltraClot, UltraClot OTCEmergency Medical Devices, LLC20080—
+4K072900Excelarrest FoamHemostasis, LLC200719—
+5K240097Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5)Ushare Medical, Inc.20240—
+5K230142Epi-Stop Nasal Gel/epistaxis packBiomed Ent, Inc.20230—
+5K202830Axiostat PatchAdvamedica, Inc.20210—
+5K190012OMNI-STAT Vascular (Rapid); CELOX Vascular RapidMedtrade Product, Ltd.20190—
+5K183622NasalCEASE and BleedCEASELes Laboratoires Brothier S.A.20190—
+5K182811gel-e Flex+Gel-E, Inc.20191—
+5K172155StatGuard Hemostatic Patch, StatGuard Hemostatic DressingStatguard, LLC20180—
+5K120782Interventional Hemostatic BandageZ-Medica Corporation20131—
+6K192667gel-e Flex+ gel OTCGel-E, Inc.20190—
+6K181641QuikClot RadialZ-Medica, LLC20180—