510(k) Report

Devices descending from K190093

3 later devices reach Rezum Delivery Device, Rezum Generator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191505Rezum SystemNxthera (A Boston Scientific Company)20192—
+2K250584Rezum SystemBoston Scientific Corporation20251—
+3K262460Rezum SystemBoston Scientific20260—