510(k) Report

Devices descending from K002583

16 later devices reach Tuna (Trans Urethra Needle) Office System through their predicates, nearest generation first.

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