510(k) Report

Devices descending from K180237

4 later devices reach Rezum System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190093Rezum Delivery Device, Rezum GeneratorNxthera (A Boston Scientific Company)20193—
+2K191505Rezum SystemNxthera (A Boston Scientific Company)20192—
+3K250584Rezum SystemBoston Scientific Corporation20251—
+4K262460Rezum SystemBoston Scientific20260—