510(k) Report

Devices descending from K010662

103 later devices reach Modification to Tissuelink Monopolar Floating Ball through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K253826Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex NeedleGalvanize Therapeutics, Inc.20260—
+9K253198NanoKnife Generator (H78720300351US0)Angiodynamics20260—
+9K233884INUMI™ Flex NeedleGalvanize Therapeutics, Inc.20241—