510(k) Report

Devices descending from K963180

13 later devices reach Vidamed RF Generator Data Recorder through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K965061Vidamed Modedl 7600 RF GeneratorVidamed, Inc.199712—
+2K052413Tuna System, Models 8909, 8929, 8930, 8934Medtronic Vascular2005101
+2K021804Precision Plus Tuna Office System; Presision Tuna Office System; Provu Tuna SystemMedtronic Vascular20020—
+3K113380Prostiva RF Therapy Hand Piece Prostiva RF Therapy RF GeneratorMedtronic, Inc.201292
+4K150786Rezum SystemNxthera, Inc.20157—
+4K142248Prostiva RF Therapy Generator, Prostiva RF Therapy Hand Piece, Prostiva RF Therapy…Urologix, Inc.20158—
+5K252388Vanquish Water Vapor Ablation DeviceFrancis Medical, Inc.20250—
+5K160417Rezum SystemNxthera, Inc.201651
+6K180237Rezum SystemNxthera, Inc.20184—
+7K190093Rezum Delivery Device, Rezum GeneratorNxthera (A Boston Scientific Company)20193—
+8K191505Rezum SystemNxthera (A Boston Scientific Company)20192—
+9K250584Rezum SystemBoston Scientific Corporation20251—
+10K262460Rezum SystemBoston Scientific20260—