510(k) Report

Devices descending from K150786

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252388Vanquish Water Vapor Ablation DeviceFrancis Medical, Inc.20250—
+1K160417Rezum SystemNxthera, Inc.201651
+2K180237Rezum SystemNxthera, Inc.20184—
+3K190093Rezum Delivery Device, Rezum GeneratorNxthera (A Boston Scientific Company)20193—
+4K191505Rezum SystemNxthera (A Boston Scientific Company)20192—
+5K250584Rezum SystemBoston Scientific Corporation20251—
+6K262460Rezum SystemBoston Scientific20260—