510(k) Report

Devices descending from K080818

11 later devices reach Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical Dressing through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150916HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO…Hem Con Medical Technologies, Inc.20153—
+1K151204HEMO-BandageCoreleader Biotech Co., Ltd.20150—
+1K093519Medtrade Products Celox Vascular Topical Hemostatic Granules on SheetMedtrade Products, Ltd.20102—
+1K090620Quikclot Inteventional, Model P/N 182Z-Medica Corporation20095—
+2K202830Axiostat PatchAdvamedica, Inc.20210—
+2K190012OMNI-STAT Vascular (Rapid); CELOX Vascular RapidMedtrade Product, Ltd.20190—
+2K182811gel-e Flex+Gel-E, Inc.20191—
+2K172155StatGuard Hemostatic Patch, StatGuard Hemostatic DressingStatguard, LLC20180—
+2K120782Interventional Hemostatic BandageZ-Medica Corporation20131—
+3K192667gel-e Flex+ gel OTCGel-E, Inc.20190—
+3K181641QuikClot RadialZ-Medica, LLC20180—