510(k) Report

Devices descending from K233884

1 later device reach INUMI™ Flex Needle through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253826Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex NeedleGalvanize Therapeutics, Inc.20260—