510(k) Report

Devices descending from K021062

48 later devices reach Chito-Seal through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102944Coreleader Hemo-Pad Model Cpii 02030Coreleader Biotech Co., Ltd.20112—
+1K080818Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical DressingHem Con Medical Technologies, Inc.200811—
+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—
+2K202830Axiostat PatchAdvamedica, Inc.20210—
+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—
+2K151204HEMO-BandageCoreleader Biotech Co., Ltd.20150—
+2K120782Interventional Hemostatic BandageZ-Medica Corporation20131—
+2K101097Calgaeseal Model: CasBz Medical, Inc.20100—
+2K093519Medtrade Products Celox Vascular Topical Hemostatic Granules on SheetMedtrade Products, Ltd.20102—
+2K092503Radar Vascular Compression DevicesAdvanced Vascular Dynamics20099—
+2K091194Algiseal PadEvolution Medical Technologies, LLC20091—
+2K090620Quikclot Inteventional, Model P/N 182Z-Medica Corporation20095—
+2K090100Softseal-STFChitogen, Inc.20092—
+2K072890Stasilon FREntegrion, Inc.20075—
+2K070175Aquanova Super-Absorbent Gelling Dressing, OtcMedtrade Products, Ltd.20076—
+2K061219D-Stat Dry Hemostatic BandageVascular Solutions, Inc.200613—
+3K212766Maxiocel Chitosan Wound DressingAdvamedica, Inc.20230—
+3K220566Vascette HP (hemostatic pad)Koag, LLC20220—
+3K190012OMNI-STAT Vascular (Rapid); CELOX Vascular RapidMedtrade Product, Ltd.20190—
+3K182811gel-e Flex+Gel-E, Inc.20191—
+3K181641QuikClot RadialZ-Medica, LLC20180—
+3K173005SURECELL Gelling Fiber Wound DressingJiangsu Newvalue Medical Producst Co.,Ltd20180—
+3K172155StatGuard Hemostatic Patch, StatGuard Hemostatic DressingStatguard, LLC20180—
+3K143124KA01 Chitosan Wound DressingFoshan United Medical Technologies, Ltd.20152—
+3K142363Nustat, Nustat XRBeeken Biomedical20154—
+3K142122Radar Vascular Compression DeviceAdvanced Vascular Dynamics20143—
+3K123041Vasostat Hemostasis DeviceForge Medical, Inc.20131—
+3K112864Softseal-CChitogen, Inc.20120—
+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—
+3K100693Aquanova AG Super Absorbant Dressing, Aquanova AG Antimicrobial DressingMedtrade Products Limited20101—
+4K222189SiOxD Wound MatrixSioxmed, LLC20222—
+4K192667gel-e Flex+ gel OTCGel-E, Inc.20190—
+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—
+4K102965Celox Trauma Gauze AG, Celox Hemostatic Antibacterial Trauma Gauze, Omni-Stat Trauma…Medtrade Products, Ltd.20100—
+5K241660SiOxD® Wound MatrixSioxmed, LLC20240—
+5K232847SiOxD Wound MatrixSioxmed, LLC20231—
+5K170958ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in / 38 cmTricol Biomedical, Inc.20170—
+5K162988PreludeSYNC Radial Compression DeviceMerit Medical Systems, Inc.201711
+6K262086PreludeSYNC™ Radial Compression DeviceMerit Medical Systems, Inc.20260—