510(k) Report

Devices descending from K984177

120 later devices reach Modification to Skvekpatch through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K153582Prometheus ChitoGauze XR PROHem Con Medical Technologies, Inc.20162—
+5K141816HemoporePolyganics B.V.,20140—
+5K111163Chitogauze FusionHem Con Medical Technologies, Inc.20110—
+5K102546ChitogauzeHem Con Medical Technologies, Inc.20109—
+5K091795Medtrade Products Celox Trauma GauzeMedtrade Products, Ltd.20097—
+5K092357Chitogauze,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—
+5K080022Gel-Sponge Ent, Absorbable Gelatin Sponge, UspVascular Solutions, Inc.20080—
+6K262086PreludeSYNC™ Radial Compression DeviceMerit Medical Systems, Inc.20260—
+6K253609TRAUMAGEL® 2.0 Hemostatic GelCresilon, Inc.20250—
+6K251845Marigen Wound Extra; Kerecis Silicone; Kerecis ParvusKerecis Limited20250—
+6K241080Kerecis Parvus (50207)Kerecis Limited20241—
+6K230589Celox Rapid X-Ray GauzeMedtrade Products, Ltd.20230—
+6K230142Epi-Stop Nasal Gel/epistaxis packBiomed Ent, Inc.20230—
+6K213231Kerecis SiliconeKerecis Limited20221—
+6K192671Hemostatic Xerogel SpongeSolaplus Biotech Co., Ltd.20200—
+6K133121Chito-Sam 100,4IN X4IN,Chito-Sam, 3IN X6FT, Chito-Sam 100,3IN X10FT, Chito-Sam Active…Sam Medical Products20145—
+7K232216Hemoblock_S (Prescription); Hemoblock_S (OTC)Incore Co., Ltd.20240—
+7K172324Axiostat Chitosan Hemostatic DressingAdvamedica, Inc.20180—
+7K143462AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use)Benq Materials Corporation20152—
+8K222909Axiostat GauzeAdvamedica, Inc.20230—