510(k) Report

Devices descending from K821150

68 later devices reach NU-Gauze Sponge through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072474Quikclot EXZ-Medica Corporation2007361
+1K984069Entaxis Nasal PackingLes Laboratorires Brothier, S.A.199937—
+2K211570Zeolite Hemostatic GauzeHangzhou Zeo-Innov Life Technology Co., Ltd.20221—
+2K183622NasalCEASE and BleedCEASELes Laboratoires Brothier S.A.20190—
+2K180893IHM Technology BandageProtege Biomedical20180—
+2K160130BloodSTOP iX Battle MatrixLifescience Plus, Inc.20160—
+2K123387Quikclot Hemostatic DressingZ-Medica, LLC201332
+2K101257Advanced Trauma Dressing (Atd)Nanosys, Inc.20110—
+2K090620Quikclot Inteventional, Model P/N 182Z-Medica Corporation20095—
+2K090026Chitogauze, Models 130, 131, 263, 264, 265, 266Hem Con Medical Technologies, Inc.200920—
+2K080648Traumastat Rapid Hemostatic Wound Dressing BandageOre-Medix, LLC20080—
+2K041446NasalceaseLes Laboratorires Brothier, S.A.20042—
+2K033666HemadermMedafor, Inc.200329—
+2K993362HylasineBiomatrix, Inc.200035—
+3K253017BloodSTOP iX Trauma Matrix (TM-iX-20)Lifescience Plus, Inc.20260—
+3K251700Ganymede 2cm diameter (FG100300); Ganymede 5cm x 5cm (FG100400); Ganymede 10cm x 10cm…Speciality Fibres and Materials Limited20260—
+3K213413Hemostatic DressingJiangsu Newvalue Medical Products Co., Ltd.20230—
+3K223495Zeolite Hemostatic CottonHangzhou Zeo-Innov Life Technology Co., Ltd.20230—
+3K172155StatGuard Hemostatic Patch, StatGuard Hemostatic DressingStatguard, LLC20180—
+3K153582Prometheus ChitoGauze XR PROHem Con Medical Technologies, Inc.20162—
+3K151204HEMO-BandageCoreleader Biotech Co., Ltd.20150—
+3K120782Interventional Hemostatic BandageZ-Medica Corporation20131—
+3K122886Nexstat Plus and Nexfoam Plus Topical Hemostat DressingHemostasis, LLC20120—
+3K111163Chitogauze FusionHem Con Medical Technologies, Inc.20110—
+3K102742Nasal CeaseCatalina, Inc.20111—
+3K102459Nexstat (TM) Topical Hemostat Powder; Nexfoam (R) Topical SpongeHemostasis, LLC20109—
+3K102546ChitogauzeHem Con Medical Technologies, Inc.20109—
+3K093519Medtrade Products Celox Vascular Topical Hemostatic Granules on SheetMedtrade Products, Ltd.20102—
+3K091795Medtrade Products Celox Trauma GauzeMedtrade Products, Ltd.20097—
+3K092357Chitogauze,2 in X 2 in,8 Ply, 4 in X 4 in 8 Ply, 4 in X 8 in, 8PLY, 1 in X 4 in, 8PLY…Hem Con Medical Technologies, Inc.200910—
+3K080818Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical DressingHem Con Medical Technologies, Inc.200811—
+3K070211Traumarrest and Bleedarrest Hemostatic Particles and FoamHemostasis, LLC200728—
+3K043035Sepragel Ent Bioresorbable Packing/StentGenzyme Corporation200510—
+4K230589Celox Rapid X-Ray GauzeMedtrade Products, Ltd.20230—
+4K192671Hemostatic Xerogel SpongeSolaplus Biotech Co., Ltd.20200—
+4K190012OMNI-STAT Vascular (Rapid); CELOX Vascular RapidMedtrade Product, Ltd.20190—
+4K181641QuikClot RadialZ-Medica, LLC20180—
+4K150916HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO…Hem Con Medical Technologies, Inc.20153—
+4K142363Nustat, Nustat XRBeeken Biomedical20154—
+4K140313Stopsbleeding Topical Hemostat Powder and FoamCoag Medical, LLC20141—
+4K133121Chito-Sam 100,4IN X4IN,Chito-Sam, 3IN X6FT, Chito-Sam 100,3IN X10FT, Chito-Sam Active…Sam Medical Products20145—
+4K132105Perclot TopicalCryolife, Inc.20140—
+4K120958Posisep and Posisep X Hemostat DressingsHemostasis, LLC20126—
+4K113585Nasal/Epistaxis PackCogent Therapeutics, LLC20127—
+4K102965Celox Trauma Gauze AG, Celox Hemostatic Antibacterial Trauma Gauze, Omni-Stat Trauma…Medtrade Products, Ltd.20100—
+4K082601UltraClot, UltraClot OTCEmergency Medical Devices, LLC20080—
+4K072900Excelarrest FoamHemostasis, LLC200719—
+4K070886Merogel Injectable Bioresorbable StentMedtronic, Inc.20071—
+5K240097Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5)Ushare Medical, Inc.20240—
+5K232216Hemoblock_S (Prescription); Hemoblock_S (OTC)Incore Co., Ltd.20240—
+5K222189SiOxD Wound MatrixSioxmed, LLC20222—
+5K202830Axiostat PatchAdvamedica, Inc.20210—
+5K182811gel-e Flex+Gel-E, Inc.20191—
+5K172324Axiostat Chitosan Hemostatic DressingAdvamedica, Inc.20180—
+5K160578Nustat XRBeeken Biomedical, LLC20160—
+5K143462AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use)Benq Materials Corporation20152—
+5K141704Novashield Injectable Nasal Packing and StentMedtronic, Inc.20142—
+5K140992Arthrocare Nasastent CMC Nasal DressingArthroCare Corporation20140—
+5K122494Posisep and Posisep X Hemostat Dressing/Intranasal SplintHemostasis, LLC20132—
+5K122434Merogel Injectable Bioresorbable Nasal Dressing and Sinus Stent and Otologic GelMedtronic Xomed20120—
+6K241660SiOxD® Wound MatrixSioxmed, LLC20240—
+6K232847SiOxD Wound MatrixSioxmed, LLC20231—
+6K222909Axiostat GauzeAdvamedica, Inc.20230—
+6K192667gel-e Flex+ gel OTCGel-E, Inc.20190—
+6K181696ChitoZolveGyrus Acmi, Inc.20180—
+6K172179Chitogel Endoscopic Sinus Surgery KitChitogel, Ltd.20171—
+6K141816HemoporePolyganics B.V.,20140—
+7K230142Epi-Stop Nasal Gel/epistaxis packBiomed Ent, Inc.20230—