510(k) Report

Devices descending from K043050

55 later devices reach Hemcon Bandage and Hemcon Bandage Otc 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—
+1K120958Posisep and Posisep X Hemostat DressingsHemostasis, LLC20126—
+1K072486Modification to Hemcon Bandage and Hemcon Bandage OtcHem Con Medical Technologies, Inc.2008356
+1K080818Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical DressingHem Con Medical Technologies, Inc.200811—
+1K072890Stasilon FREntegrion, Inc.20075—
+1K071519Hemcon Chitoflex-Surgical DressingHemcon, Inc.200722—
+2K202830Axiostat PatchAdvamedica, Inc.20210—
+2K182811gel-e Flex+Gel-E, Inc.20191—
+2K180152gel-e FlexGel-E, Inc.20182—
+2K151204HEMO-BandageCoreleader Biotech Co., Ltd.20150—
+2K142363Nustat, Nustat XRBeeken Biomedical20154—
+2K141704Novashield Injectable Nasal Packing and StentMedtronic, Inc.20142—
+2K132343Marigen Wound DressingKerecis Limited20135—
+2K123387Quikclot Hemostatic DressingZ-Medica, LLC201332
+2K122494Posisep and Posisep X Hemostat Dressing/Intranasal SplintHemostasis, LLC20132—
+2K093519Medtrade Products Celox Vascular Topical Hemostatic Granules on SheetMedtrade Products, Ltd.20102—
+2K090620Quikclot Inteventional, Model P/N 182Z-Medica Corporation20095—
+2K090026Chitogauze, Models 130, 131, 263, 264, 265, 266Hem Con Medical Technologies, Inc.200920—
+2K080648Traumastat Rapid Hemostatic Wound Dressing BandageOre-Medix, LLC20080—
+3K253017BloodSTOP iX Trauma Matrix (TM-iX-20)Lifescience Plus, Inc.20260—
+3K251700Ganymede 2cm diameter (FG100300); Ganymede 5cm x 5cm (FG100400); Ganymede 10cm x 10cm…Speciality Fibres and Materials Limited20260—
+3K213413Hemostatic DressingJiangsu Newvalue Medical Products Co., Ltd.20230—
+3K213652Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG)Cresilon, Inc.20231—
+3K222189SiOxD Wound MatrixSioxmed, LLC20222—
+3K190012OMNI-STAT Vascular (Rapid); CELOX Vascular RapidMedtrade Product, Ltd.20190—
+3K192667gel-e Flex+ gel OTCGel-E, Inc.20190—
+3K190528MariGen Wound ExtraKerecis Limited20193—
+3K181696ChitoZolveGyrus Acmi, Inc.20180—
+3K172155StatGuard Hemostatic Patch, StatGuard Hemostatic DressingStatguard, LLC20180—
+3K172179Chitogel Endoscopic Sinus Surgery KitChitogel, Ltd.20171—
+3K153364Kerecis SecureMeshKerecis Limited20160—
+3K160578Nustat XRBeeken Biomedical, LLC20160—
+3K153582Prometheus ChitoGauze XR PROHem Con Medical Technologies, Inc.20162—
+3K141816HemoporePolyganics B.V.,20140—
+3K120782Interventional Hemostatic BandageZ-Medica Corporation20131—
+3K111163Chitogauze FusionHem Con Medical Technologies, Inc.20110—
+3K102546ChitogauzeHem Con Medical Technologies, Inc.20109—
+3K091795Medtrade Products Celox Trauma GauzeMedtrade Products, Ltd.20097—
+3K092357Chitogauze,2 in X 2 in,8 Ply, 4 in X 4 in 8 Ply, 4 in X 8 in, 8PLY, 1 in X 4 in, 8PLY…Hem Con Medical Technologies, Inc.200910—
+4K253609TRAUMAGEL® 2.0 Hemostatic GelCresilon, Inc.20250—
+4K251845Marigen Wound Extra; Kerecis Silicone; Kerecis ParvusKerecis Limited20250—
+4K241080Kerecis Parvus (50207)Kerecis Limited20241—
+4K241660SiOxD® Wound MatrixSioxmed, LLC20240—
+4K232847SiOxD Wound MatrixSioxmed, LLC20231—
+4K230589Celox Rapid X-Ray GauzeMedtrade Products, Ltd.20230—
+4K230142Epi-Stop Nasal Gel/epistaxis packBiomed Ent, Inc.20230—
+4K213231Kerecis SiliconeKerecis Limited20221—
+4K192671Hemostatic Xerogel SpongeSolaplus Biotech Co., Ltd.20200—
+4K181641QuikClot RadialZ-Medica, LLC20180—
+4K133121Chito-Sam 100,4IN X4IN,Chito-Sam, 3IN X6FT, Chito-Sam 100,3IN X10FT, Chito-Sam Active…Sam Medical Products20145—
+4K102965Celox Trauma Gauze AG, Celox Hemostatic Antibacterial Trauma Gauze, Omni-Stat Trauma…Medtrade Products, Ltd.20100—
+5K232216Hemoblock_S (Prescription); Hemoblock_S (OTC)Incore Co., Ltd.20240—
+5K172324Axiostat Chitosan Hemostatic DressingAdvamedica, Inc.20180—
+5K143462AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use)Benq Materials Corporation20152—
+6K222909Axiostat GauzeAdvamedica, Inc.20230—