510(k) Report

Devices descending from K080097

18 later devices reach Medtrade Products Celox Hemostatic Granules on Sheet through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143462AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use)Benq Materials Corporation20152—
+1K133121Chito-Sam 100,4IN X4IN,Chito-Sam, 3IN X6FT, Chito-Sam 100,3IN X10FT, Chito-Sam Active…Sam Medical Products20145—
+1K113560Celox Gauze ProMedtrade Products, Ltd.201211—
+1K110386Celox Rapid GauzeMedtrade Products, Ltd.20111—
+1K093519Medtrade Products Celox Vascular Topical Hemostatic Granules on SheetMedtrade Products, Ltd.20102—
+1K091795Medtrade Products Celox Trauma GauzeMedtrade Products, Ltd.20097—
+2K240713Traumagel®Cresilon, Inc.20242—
+2K232216Hemoblock_S (Prescription); Hemoblock_S (OTC)Incore Co., Ltd.20240—
+2K230589Celox Rapid X-Ray GauzeMedtrade Products, Ltd.20230—
+2K222909Axiostat GauzeAdvamedica, Inc.20230—
+2K190012OMNI-STAT Vascular (Rapid); CELOX Vascular RapidMedtrade Product, Ltd.20190—
+2K172155StatGuard Hemostatic Patch, StatGuard Hemostatic DressingStatguard, LLC20180—
+2K172324Axiostat Chitosan Hemostatic DressingAdvamedica, Inc.20180—
+2K151204HEMO-BandageCoreleader Biotech Co., Ltd.20150—
+2K132333Bondiloxs Topical Hemostatic DressingMedtrade Products, Ltd.20140—
+2K102965Celox Trauma Gauze AG, Celox Hemostatic Antibacterial Trauma Gauze, Omni-Stat Trauma…Medtrade Products, Ltd.20100—
+3K250319Mfuse (MS001)Machina Medical, Inc.20250—
+3K253609TRAUMAGEL® 2.0 Hemostatic GelCresilon, Inc.20250—