510(k) Report

Devices descending from K071578

3 later devices reach Bloodstop and Bloodstop IX Hemostatic Gauze, Models BS-10,BS-11,BS-12,B-13… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160679WoundClot9Core Scientific Creation, Ltd.20160—
+1K112800Suntouch Topical Hemostatic DressingHuizhou Foryou Medical Devices Co., Ltd.201201
+1K082601UltraClot, UltraClot OTCEmergency Medical Devices, LLC20080—