510(k) Report

Devices descending from K160417

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180237Rezum SystemNxthera, Inc.20184—
+2K190093Rezum Delivery Device, Rezum GeneratorNxthera (A Boston Scientific Company)20193—
+3K191505Rezum SystemNxthera (A Boston Scientific Company)20192—
+4K250584Rezum SystemBoston Scientific Corporation20251—
+5K262460Rezum SystemBoston Scientific20260—