510(k) Report

Devices descending from K042619

8 later devices reach Ultrabio - in Vivo Biocompatible, Bioeliminated Sterile Ultrasound Imaging… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130041Sheathes Sterile Ultrasound GelSheathing Technologies, Inc.20135—
+1K083358Lubricano-UltrasoundFarco Pharma GmbH20091—
+2K211691Ultrast GelUltrast, Inc.20210—
+2K181363EcoVue Sterile and Non-Sterile Ultrasound GelsH R Pharmaceuticals, Inc.20184—
+3K242167Sterile and Non-Sterile Ultrasonic Coupling AgentAnhui Deepblue Medical Technology Co., Ltd.20240—
+3K241789Non-Sterile Ultrasound Transmission GelsHony Medical Co., Ltd.20240—
+3K232957Sterile and Non-Sterile Ultrasound GelsJianerkang Medical Co., Ltd.20230—
+3K221999Ultrasound Transmission GelsHony Medical Co., Ltd.20220—