510(k) Report

Devices descending from K210476

2 later devices reach EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241209EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)Cook Ireland, Ltd.20240—
+1K230909EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)Cook Ireland, Ltd.20231—