510(k) Report

Devices descending from K193517

2 later devices reach ViziShot 2 FLEX through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K261274EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip…Cook Ireland, Ltd.20260—
+1K251402LIA-1 Catheter (542-1)Leadoptik, Inc.20250—