510(k) Report

Devices descending from K110088

2 later devices reach Defendo Y-Opsy Irrigator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200481Andorate Biopsy Valve, Andorate Biopsy IrrigatorGa Health Company Limited20201—
+2K230932ANDORATE® Valve KitGa Health Company Limited20230—