510(k) Report

Devices descending from K984177

120 later devices reach Modification to Skvekpatch through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143466Hemogrip PatchRemedium Technologies, Inc.20150—
+1K070557MP 719Marine Polymer Technologies, Inc.20072—
+1K053300SyvekexcelMarine Polymer Technologies, Inc.200614—
+1K040208Neptune Pad, Neptune Disc, Neptune Comfort-Band, Comfort-BandTz Medical, Inc.2004141
+1K032986Clo-Surplusp.a.D.Scion Cardio-Vascular, Inc.200425—
+1K033666HemadermMedafor, Inc.200329—
+1K030946Hemcon Bandage Otc; Hemcon Cath/AidHemcon, Inc.200356—
+1K030334T-Scientific T-PadT-Scientific, Inc.200344—
+1K021062Chito-SealAbbott Vascular, Inc.200248—
+1K012293Vascular Solutions Duett Flowable HemostatVascular Solutions, Inc.200245—
+2K161013InnoSEAL Hemostatic PadInnotherapy, Inc.20160—
+2K150916HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO…Hem Con Medical Technologies, Inc.20153—
+2K150963AnsCare ChitoClot PadBenq Materials Corporation20150—
+2K120782Interventional Hemostatic BandageZ-Medica Corporation20131—
+2K122886Nexstat Plus and Nexfoam Plus Topical Hemostat DressingHemostasis, LLC20120—
+2K102944Coreleader Hemo-Pad Model Cpii 02030Coreleader Biotech Co., Ltd.20112—
+2K111524MP 719Marine Polymer Technologies, Inc.20110—
+2K102459Nexstat (TM) Topical Hemostat Powder; Nexfoam (R) Topical SpongeHemostasis, LLC20109—
+2K101097Calgaeseal Model: CasBz Medical, Inc.20100—
+2K102002TalymedMarine Polymer Technologies20100—
+2K092503Radar Vascular Compression DevicesAdvanced Vascular Dynamics20099—
+2K091194Algiseal PadEvolution Medical Technologies, LLC20091—
+2K090100Softseal-STFChitogen, Inc.20092—
+2K080818Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical DressingHem Con Medical Technologies, Inc.200811—
+2K072890Stasilon FREntegrion, Inc.20075—
+2K070938Thrombi-Paste Thrombin/Gelatin Powder Paste HemostatVascular Solutions, Inc.20070—
+2K070175Aquanova Super-Absorbent Gelling Dressing, OtcMedtrade Products, Ltd.20076—
+2K070211Traumarrest and Bleedarrest Hemostatic Particles and FoamHemostasis, LLC200728—
+2K061219D-Stat Dry Hemostatic BandageVascular Solutions, Inc.200613—
+2K043050Hemcon Bandage and Hemcon Bandage OtcHemcon, Inc.200555—
+2K030836D-Stat-Dry Hemostatic Bandage; D-Stat Radial Hemostatic BandageVascular Solutions, Inc.2003443
+3K212766Maxiocel Chitosan Wound DressingAdvamedica, Inc.20230—
+3K220566Vascette HP (hemostatic pad)Koag, LLC20220—
+3K202830Axiostat PatchAdvamedica, Inc.20210—
+3K182811gel-e Flex+Gel-E, Inc.20191—
+3K181641QuikClot RadialZ-Medica, LLC20180—
+3K173005SURECELL Gelling Fiber Wound DressingJiangsu Newvalue Medical Producst Co.,Ltd20180—
+3K151204HEMO-BandageCoreleader Biotech Co., Ltd.20150—
+3K143124KA01 Chitosan Wound DressingFoshan United Medical Technologies, Ltd.20152—
+3K142363Nustat, Nustat XRBeeken Biomedical20154—
+3K142122Radar Vascular Compression DeviceAdvanced Vascular Dynamics20143—
+3K140313Stopsbleeding Topical Hemostat Powder and FoamCoag Medical, LLC20141—
+3K132105Perclot TopicalCryolife, Inc.20140—
+3K123041Vasostat Hemostasis DeviceForge Medical, Inc.20131—
+3K112864Softseal-CChitogen, Inc.20120—
+3K120958Posisep and Posisep X Hemostat DressingsHemostasis, LLC20126—
+3K111837Radial Artery Compression TourniquetLepu Medical Technology (Beijing) Co., Ltd.20114—
+3K102212D-Stat Dry Silver; D-Stat Dry Clear Silver; D-Stat Dry Wrap Silver; Thrombix SilverVascular Solutions, Inc.20110—
+3K102742Nasal CeaseCatalina, Inc.20111—
+3K100693Aquanova AG Super Absorbant Dressing, Aquanova AG Antimicrobial DressingMedtrade Products Limited20101—
+3K093519Medtrade Products Celox Vascular Topical Hemostatic Granules on SheetMedtrade Products, Ltd.20102—
+3K090620Quikclot Inteventional, Model P/N 182Z-Medica Corporation20095—
+3K082601UltraClot, UltraClot OTCEmergency Medical Devices, LLC20080—
+3K072486Modification to Hemcon Bandage and Hemcon Bandage OtcHem Con Medical Technologies, Inc.2008356
+3K073264D-Stat Dry Clear Hemostatic Bandage, Model 3005Vascular Solutions, Inc.20073—
+3K072900Excelarrest FoamHemostasis, LLC200719—
+3K072117Thrombix Patch Thrombin Hemostasis PatchVascular Solutions, Inc.20072—
+3K071519Hemcon Chitoflex-Surgical DressingHemcon, Inc.200722—
+3K050146Vascular Solutions D-Stat Clamp AccessoryVascular Solutions, Inc.200516—
+3K050511Thrombigel Thrombin/Gelatin Foam HemostatVascular Solutions, Inc.200525—
+3K050133D-Stat Radial Hemostatic BandVascular Solutions, Inc.20052—
+3K040118Vascular Solutions D-Stat Dry Hemostatic Bandage, the D-Stat Radial Hemostatic Band and…Vascular Solutions, Inc.20040—
+4K240097Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5)Ushare Medical, Inc.20240—
+4K222189SiOxD Wound MatrixSioxmed, LLC20222—
+4K200720D-Stat Radial Topical HemostatVascular Solutions, LLC20200—
+4K190012OMNI-STAT Vascular (Rapid); CELOX Vascular RapidMedtrade Product, Ltd.20190—
+4K183622NasalCEASE and BleedCEASELes Laboratoires Brothier S.A.20190—
+4K192667gel-e Flex+ gel OTCGel-E, Inc.20190—
+4K180152gel-e FlexGel-E, Inc.20182—
+4K172155StatGuard Hemostatic Patch, StatGuard Hemostatic DressingStatguard, LLC20180—
+4K172010gel-e BandageGel-E, Inc. (Formerly Remedium Technologies, Inc.)20170—
+4K160578Nustat XRBeeken Biomedical, LLC20160—
+4K153259VasoStat Hemostasis DeviceForge Medical, Inc.20160—
+4K151363Zephyr Vascular Compression DeviceAdvanced Vascular Dynamics20151—
+4K142359Vasc Band hemostatLepu Medical Technology (Beijing) Co., Ltd.20143—
+4K141704Novashield Injectable Nasal Packing and StentMedtronic, Inc.20142—
+4K132343Marigen Wound DressingKerecis Limited20135—
+4K123387Quikclot Hemostatic DressingZ-Medica, LLC201332
+4K122494Posisep and Posisep X Hemostat Dressing/Intranasal SplintHemostasis, LLC20132—
+4K102965Celox Trauma Gauze AG, Celox Hemostatic Antibacterial Trauma Gauze, Omni-Stat Trauma…Medtrade Products, Ltd.20100—
+4K092612D-Stat Rad-Band, Rad-Band, Models 3501, 3505Vascular Solutions, Inc.20090—
+4K090026Chitogauze, Models 130, 131, 263, 264, 265, 266Hem Con Medical Technologies, Inc.200920—
+4K083190D-Stat Dry Wrap Hemostatic Bandage, Model: 3015Vascular Solutions, Inc.20081—
+4K080648Traumastat Rapid Hemostatic Wound Dressing BandageOre-Medix, LLC20080—
+4K063871D-Stat Handle, Model 8500-053Vascular Solutions, Inc.20070—
+4K063860Thrombigel Thrombin/Gelatin Foam HemostatVascular Solutions, Inc.20072—
+4K053644Thrombigel Thrombin/Gelatin Foam HemostatVascular Solutions, Inc.20063—
+4K053054Thrombix 3X3 Hemostatic PadVascular Solutions, Inc.20050—
+5K253017BloodSTOP iX Trauma Matrix (TM-iX-20)Lifescience Plus, Inc.20260—
+5K251700Ganymede 2cm diameter (FG100300); Ganymede 5cm x 5cm (FG100400); Ganymede 10cm x 10cm…Speciality Fibres and Materials Limited20260—
+5K241660SiOxD® Wound MatrixSioxmed, LLC20240—
+5K232847SiOxD Wound MatrixSioxmed, LLC20231—
+5K213413Hemostatic DressingJiangsu Newvalue Medical Products Co., Ltd.20230—
+5K213652Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG)Cresilon, Inc.20231—
+5K190528MariGen Wound ExtraKerecis Limited20193—
+5K181696ChitoZolveGyrus Acmi, Inc.20180—
+5K172179Chitogel Endoscopic Sinus Surgery KitChitogel, Ltd.20171—
+5K170958ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in / 38 cmTricol Biomedical, Inc.20170—
+5K162988PreludeSYNC Radial Compression DeviceMerit Medical Systems, Inc.201711
+5K153364Kerecis SecureMeshKerecis Limited20160—