510(k) Report

Devices descending from K112827

8 later devices reach Sheathes Ultrasond Gel through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181363EcoVue Sterile and Non-Sterile Ultrasound GelsH R Pharmaceuticals, Inc.20184—
+1K131905Solid Gel PadBluemtech20131—
+1K130041Sheathes Sterile Ultrasound GelSheathing Technologies, Inc.20135—
+2K252337EdgeFlow Gel PadEdgecare, Inc.20260—
+2K242167Sterile and Non-Sterile Ultrasonic Coupling AgentAnhui Deepblue Medical Technology Co., Ltd.20240—
+2K241789Non-Sterile Ultrasound Transmission GelsHony Medical Co., Ltd.20240—
+2K232957Sterile and Non-Sterile Ultrasound GelsJianerkang Medical Co., Ltd.20230—
+2K221999Ultrasound Transmission GelsHony Medical Co., Ltd.20220—