510(k) Report

Devices descending from K980989

37 later devices reach 3M Tegagen HI Alginate Dressing & 3M Tegagen HG Alginate Dressing through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K010933Seal-on Topical Hempstatic Powder SprayAlltracel Pharma, Ltd.200235—
+1K9826383M Tegagen HI Alginate Dressing & 3 M Tegagen HG Alginate Dressing, Model #'S…Innovative Technologies, Ltd.19980—
+2K210751S.E.A.L. Hemostatic Wound SprayBc3 Technologies, Inc.20230—
+2K112215Hemcon Hemostatic GelHemcon Medical Technologies Europe, Ltd.20120—
+2K093729Guardiva Antimicrobial Haemostatic IV Dressing, 1 in/ 4MM, Sterile, Guard Iva…Hemcon Medical Technologies Europe, Ltd.20101—
+2K072681Bloodstop Hemostatic Gauze; IX Hemostatic GauzeLifescience Plus, Inc.20076—
+2K071578Bloodstop and Bloodstop IX Hemostatic Gauze, Models BS-10,BS-11,BS-12,B-13, BS-IX27…Lifescience Plus, Inc.20073—
+2K024107Femostop Femoral Compression SystemRadi Medical Systems AB200223—
+3K160679WoundClot9Core Scientific Creation, Ltd.20160—
+3K160130BloodSTOP iX Battle MatrixLifescience Plus, Inc.20160—
+3K121485Guardiva Antimicrobial Haemstatic IV DressingHemcon Medical Technologies Europe, Ltd.20120—
+3K112800Suntouch Topical Hemostatic DressingHuizhou Foryou Medical Devices Co., Ltd.201201
+3K103245CelstatBaxter Healthcare Corp20110—
+3K110193Femostop Plys, Femostop HD, Femostop Compression Arch; Femostop II Plus Set; Femostop II…St. Jude Medical Systems AB20110—
+3K082601UltraClot, UltraClot OTCEmergency Medical Devices, LLC20080—
+3K080206Modification to Femostop Femoral Compression SystemRadi Medical Systems AB20083—
+3K053300SyvekexcelMarine Polymer Technologies, Inc.200614—
+3K040730Vascular Solutions D-Stat Clamp Hemostatic ClampVascular Solutions, Inc.200417—
+3K033291Topseal Hemostatic Dressing, Model 11150Radi Medical Systems AB20040—
+4K192413SiteSeal Femoral Compression DeviceEnsite Vacular, LLC20200—
+4K120204Reprocessed Femoral Compression DeviceSterilmed, Inc.20120—
+4K072890Stasilon FREntegrion, Inc.20075—
+4K061219D-Stat Dry Hemostatic BandageVascular Solutions, Inc.200613—
+4K050146Vascular Solutions D-Stat Clamp AccessoryVascular Solutions, Inc.200516—
+5K142363Nustat, Nustat XRBeeken Biomedical20154—
+5K102212D-Stat Dry Silver; D-Stat Dry Clear Silver; D-Stat Dry Wrap Silver; Thrombix SilverVascular Solutions, Inc.20110—
+5K093519Medtrade Products Celox Vascular Topical Hemostatic Granules on SheetMedtrade Products, Ltd.20102—
+5K090620Quikclot Inteventional, Model P/N 182Z-Medica Corporation20095—
+5K063871D-Stat Handle, Model 8500-053Vascular Solutions, Inc.20070—
+6K222189SiOxD Wound MatrixSioxmed, LLC20222—
+6K190012OMNI-STAT Vascular (Rapid); CELOX Vascular RapidMedtrade Product, Ltd.20190—
+6K172155StatGuard Hemostatic Patch, StatGuard Hemostatic DressingStatguard, LLC20180—
+6K160578Nustat XRBeeken Biomedical, LLC20160—
+6K120782Interventional Hemostatic BandageZ-Medica Corporation20131—
+7K241660SiOxD® Wound MatrixSioxmed, LLC20240—
+7K232847SiOxD Wound MatrixSioxmed, LLC20231—
+7K181641QuikClot RadialZ-Medica, LLC20180—