510(k) Report

Devices descending from K090026

20 later devices reach Chitogauze, Models 130, 131, 263, 264, 265, 266 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213413Hemostatic DressingJiangsu Newvalue Medical Products Co., Ltd.20230—
+1K172155StatGuard Hemostatic Patch, StatGuard Hemostatic DressingStatguard, LLC20180—
+1K153582Prometheus ChitoGauze XR PROHem Con Medical Technologies, Inc.20162—
+1K111163Chitogauze FusionHem Con Medical Technologies, Inc.20110—
+1K102546ChitogauzeHem Con Medical Technologies, Inc.20109—
+1K091795Medtrade Products Celox Trauma GauzeMedtrade Products, Ltd.20097—
+1K092357Chitogauze,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—
+2K230589Celox Rapid X-Ray GauzeMedtrade Products, Ltd.20230—
+2K192671Hemostatic Xerogel SpongeSolaplus Biotech Co., Ltd.20200—
+2K142363Nustat, Nustat XRBeeken Biomedical20154—
+2K133121Chito-Sam 100,4IN X4IN,Chito-Sam, 3IN X6FT, Chito-Sam 100,3IN X10FT, Chito-Sam Active…Sam Medical Products20145—
+2K102965Celox Trauma Gauze AG, Celox Hemostatic Antibacterial Trauma Gauze, Omni-Stat Trauma…Medtrade Products, Ltd.20100—
+3K232216Hemoblock_S (Prescription); Hemoblock_S (OTC)Incore Co., Ltd.20240—
+3K222189SiOxD Wound MatrixSioxmed, LLC20222—
+3K172324Axiostat Chitosan Hemostatic DressingAdvamedica, Inc.20180—
+3K160578Nustat XRBeeken Biomedical, LLC20160—
+3K143462AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use)Benq Materials Corporation20152—
+4K241660SiOxD® Wound MatrixSioxmed, LLC20240—
+4K232847SiOxD Wound MatrixSioxmed, LLC20231—
+4K222909Axiostat GauzeAdvamedica, Inc.20230—