510(k) Report

Devices descending from K113560

11 later devices reach Celox Gauze Pro through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240713Traumagel®Cresilon, Inc.20242—
+1K151204HEMO-BandageCoreleader Biotech Co., Ltd.20150—
+1K143462AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use)Benq Materials Corporation20152—
+1K132333Bondiloxs Topical Hemostatic DressingMedtrade Products, Ltd.20140—
+1K133121Chito-Sam 100,4IN X4IN,Chito-Sam, 3IN X6FT, Chito-Sam 100,3IN X10FT, Chito-Sam Active…Sam Medical Products20145—
+2K250319Mfuse (MS001)Machina Medical, Inc.20250—
+2K253609TRAUMAGEL® 2.0 Hemostatic GelCresilon, Inc.20250—
+2K232216Hemoblock_S (Prescription); Hemoblock_S (OTC)Incore Co., Ltd.20240—
+2K222909Axiostat GauzeAdvamedica, Inc.20230—
+2K172155StatGuard Hemostatic Patch, StatGuard Hemostatic DressingStatguard, LLC20180—
+2K172324Axiostat Chitosan Hemostatic DressingAdvamedica, Inc.20180—