510(k) Report

Devices descending from K133121

5 later devices reach Chito-Sam 100,4IN X4IN,Chito-Sam, 3IN X6FT, Chito-Sam 100,3IN X10FT, Chito-Sam… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232216Hemoblock_S (Prescription); Hemoblock_S (OTC)Incore Co., Ltd.20240—
+1K172324Axiostat Chitosan Hemostatic DressingAdvamedica, Inc.20180—
+1K143462AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use)Benq Materials Corporation20152—
+2K222909Axiostat GauzeAdvamedica, Inc.20230—
+2K172155StatGuard Hemostatic Patch, StatGuard Hemostatic DressingStatguard, LLC20180—