510(k) Report

Devices descending from K071519

22 later devices reach 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—
+1K132343Marigen Wound DressingKerecis Limited20135—
+1K123387Quikclot Hemostatic DressingZ-Medica, LLC201332
+1K080818Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical DressingHem Con Medical Technologies, Inc.200811—
+1K080648Traumastat Rapid Hemostatic Wound Dressing BandageOre-Medix, LLC20080—
+2K253017BloodSTOP iX Trauma Matrix (TM-iX-20)Lifescience Plus, Inc.20260—
+2K251700Ganymede 2cm diameter (FG100300); Ganymede 5cm x 5cm (FG100400); Ganymede 10cm x 10cm…Speciality Fibres and Materials Limited20260—
+2K202830Axiostat PatchAdvamedica, Inc.20210—
+2K182811gel-e Flex+Gel-E, Inc.20191—
+2K190528MariGen Wound ExtraKerecis Limited20193—
+2K153364Kerecis SecureMeshKerecis Limited20160—
+2K151204HEMO-BandageCoreleader Biotech Co., Ltd.20150—
+2K093519Medtrade Products Celox Vascular Topical Hemostatic Granules on SheetMedtrade Products, Ltd.20102—
+2K090620Quikclot Inteventional, Model P/N 182Z-Medica Corporation20095—
+3K251845Marigen Wound Extra; Kerecis Silicone; Kerecis ParvusKerecis Limited20250—
+3K241080Kerecis Parvus (50207)Kerecis Limited20241—
+3K213231Kerecis SiliconeKerecis Limited20221—
+3K190012OMNI-STAT Vascular (Rapid); CELOX Vascular RapidMedtrade Product, Ltd.20190—
+3K192667gel-e Flex+ gel OTCGel-E, Inc.20190—
+3K172155StatGuard Hemostatic Patch, StatGuard Hemostatic DressingStatguard, LLC20180—
+3K120782Interventional Hemostatic BandageZ-Medica Corporation20131—
+4K181641QuikClot RadialZ-Medica, LLC20180—