510(k) Report

Devices descending from K142248

8 later devices reach Prostiva RF Therapy Generator, Prostiva RF Therapy Hand Piece, Prostiva RF… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150786Rezum SystemNxthera, Inc.20157—
+2K252388Vanquish Water Vapor Ablation DeviceFrancis Medical, Inc.20250—
+2K160417Rezum SystemNxthera, Inc.201651
+3K180237Rezum SystemNxthera, Inc.20184—
+4K190093Rezum Delivery Device, Rezum GeneratorNxthera (A Boston Scientific Company)20193—
+5K191505Rezum SystemNxthera (A Boston Scientific Company)20192—
+6K250584Rezum SystemBoston Scientific Corporation20251—
+7K262460Rezum SystemBoston Scientific20260—