510(k) Report

Devices descending from K090217

2 later devices reach Bonee Needle for Bladder Injections, MODELSNBI035, NBI070 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192498Single Use InjectorOlympus Medical Systems Corp.20201—
+2K250522Multi4 SystemMulti4 Medical AB20250—