510(k) Report

Devices descending from K050511

25 later devices reach Thrombigel Thrombin/Gelatin Foam Hemostat through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072900Excelarrest FoamHemostasis, LLC200719—
+1K063860Thrombigel Thrombin/Gelatin Foam HemostatVascular Solutions, Inc.20072—
+1K053644Thrombigel Thrombin/Gelatin Foam HemostatVascular Solutions, Inc.20063—
+1K053054Thrombix 3X3 Hemostatic PadVascular Solutions, Inc.20050—
+2K120958Posisep and Posisep X Hemostat DressingsHemostasis, LLC20126—
+2K080022Gel-Sponge Ent, Absorbable Gelatin Sponge, UspVascular Solutions, Inc.20080—
+2K080818Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical DressingHem Con Medical Technologies, Inc.200811—
+2K070938Thrombi-Paste Thrombin/Gelatin Powder Paste HemostatVascular Solutions, Inc.20070—
+3K150916HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO…Hem Con Medical Technologies, Inc.20153—
+3K151204HEMO-BandageCoreleader Biotech Co., Ltd.20150—
+3K141704Novashield Injectable Nasal Packing and StentMedtronic, Inc.20142—
+3K122494Posisep and Posisep X Hemostat Dressing/Intranasal SplintHemostasis, LLC20132—
+3K093519Medtrade Products Celox Vascular Topical Hemostatic Granules on SheetMedtrade Products, Ltd.20102—
+3K090620Quikclot Inteventional, Model P/N 182Z-Medica Corporation20095—
+4K202830Axiostat PatchAdvamedica, Inc.20210—
+4K190012OMNI-STAT Vascular (Rapid); CELOX Vascular RapidMedtrade Product, Ltd.20190—
+4K182811gel-e Flex+Gel-E, Inc.20191—
+4K181696ChitoZolveGyrus Acmi, Inc.20180—
+4K172155StatGuard Hemostatic Patch, StatGuard Hemostatic DressingStatguard, LLC20180—
+4K172179Chitogel Endoscopic Sinus Surgery KitChitogel, Ltd.20171—
+4K141816HemoporePolyganics B.V.,20140—
+4K120782Interventional Hemostatic BandageZ-Medica Corporation20131—
+5K230142Epi-Stop Nasal Gel/epistaxis packBiomed Ent, Inc.20230—
+5K192667gel-e Flex+ gel OTCGel-E, Inc.20190—
+5K181641QuikClot RadialZ-Medica, LLC20180—