510(k) Report

Devices descending from K091795

7 later devices reach Medtrade Products Celox Trauma Gauze through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133121Chito-Sam 100,4IN X4IN,Chito-Sam, 3IN X6FT, Chito-Sam 100,3IN X10FT, Chito-Sam Active…Sam Medical Products20145—
+1K102965Celox Trauma Gauze AG, Celox Hemostatic Antibacterial Trauma Gauze, Omni-Stat Trauma…Medtrade Products, Ltd.20100—
+2K232216Hemoblock_S (Prescription); Hemoblock_S (OTC)Incore Co., Ltd.20240—
+2K172324Axiostat Chitosan Hemostatic DressingAdvamedica, Inc.20180—
+2K143462AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use)Benq Materials Corporation20152—
+3K222909Axiostat GauzeAdvamedica, Inc.20230—
+3K172155StatGuard Hemostatic Patch, StatGuard Hemostatic DressingStatguard, LLC20180—