510(k) Report

Devices descending from K960918

19 later devices reach Vidamed Tuna (Transurethral Needle Ablation) System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052413Tuna System, Models 8909, 8929, 8930, 8934Medtronic Vascular2005101
+1K011190Surx Radiofrequency Electrosurgical Generator System and Accessories (Surx LP System)Surx, Inc.20023—
+1K991847Thermoflex SystemArgomed, Inc.19990—
+1K965199Tuna 5 CatheterVidamed, Inc.19975—
+1K965061Vidamed Modedl 7600 RF GeneratorVidamed, Inc.199712—
+2K113380Prostiva RF Therapy Hand Piece Prostiva RF Therapy RF GeneratorMedtronic, Inc.201292
+2K021804Precision Plus Tuna Office System; Presision Tuna Office System; Provu Tuna SystemMedtronic Vascular20020—
+2K020952Surx RF SystemSurx, Inc.20021—
+2K020126Modification to Surx Radiofrequency Electrosurgical Generator System and Accessories…Surx, Inc.20022—
+3K150786Rezum SystemNxthera, Inc.20157—
+3K142248Prostiva RF Therapy Generator, Prostiva RF Therapy Hand Piece, Prostiva RF Therapy…Urologix, Inc.20158—
+3K042132Novasys Transurethral RF SystemNovasys Medical, Inc.200401
+4K252388Vanquish Water Vapor Ablation DeviceFrancis Medical, Inc.20250—
+4K160417Rezum SystemNxthera, Inc.201651
+5K180237Rezum SystemNxthera, Inc.20184—
+6K190093Rezum Delivery Device, Rezum GeneratorNxthera (A Boston Scientific Company)20193—
+7K191505Rezum SystemNxthera (A Boston Scientific Company)20192—
+8K250584Rezum SystemBoston Scientific Corporation20251—
+9K262460Rezum SystemBoston Scientific20260—