510(k) Report

Devices descending from K992581

23 later devices reach Arthrocare Controller, Arthrocare Cable, Footswitch, Powercord, Spine Wands… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K091310Ablation Instrument, Model 1635; Ablation Multiplex Catheter, Model 1682Dfine, Inc.201011—
+1K033547Vnus Vessel and Tissue Coagulation SystemVnus Medical Technologies, Inc.20046—
+1K012631Reprocessed Soft Tissue AblatorsAlliance Medical Corp.20011—
+1K012679Reprocessed RF Arthroscopy ProbesSterilmed, Inc.200101
+1K012129Ortho Development Orion-I Emf SystemOrtho Development Corp.20010—
+2K142480OsteoCool V-2 RF Ablation SystemBaylis Medical Company, Inc.20159—
+2K111523Osteocool (TM) RF Ablation SystemBaylis Medical Co., Inc.20120—
+2K052692Suretek Medical Reprocessed Electrosurgical ElectrodesSuretek Medical20060—
+2K052003Vnus RFS, Model RFS-6-XX (XX = 10, 12, 13, & 15); Vnus RFS Flex, Model RFX-6-XX (XX =…Vnus Medical Technologies, Inc.20055—
+3K211806Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF…Venclose, Inc.202121
+3K181044400um Perforator and Accessory Vein Ablation KitAngioDynamics, Inc.20180—
+3K173214NES Reprocessed RF Stylet (RFS)Northeast Scientific, Inc. (Nes)20180—
+3K152057OsteoCool V-3 RF Ablation SystemBaylis Medical Company, Inc.20158—
+4K250068Venclose digiRF Generator (VCRFG1)Venclose, Inc.202511
+4K161949OsteoCool V-3 RF Ablation SystemBaylis Medical Company, Inc.20177—
+5K252316Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100)Venclose, Inc.20250—
+5K192406AveCure BT Microwave Ablation SystemMedwaves, Inc.20200—
+5K182497OsteoCool RF Ablation SystemMedtronic Sofamor Danek USA, Inc.20195—
+6K233830OsteoCool™ 2.0 RF Ablation SystemMedtronic Sofamor Danek USA, Inc.20241—
+6K223303Spinery™ RF Ablation SystemAxon Spine Medical System20230—
+6K221074OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion DeviceStryker Corporation20222—
+7K253656OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K250327OptaBlate Radiofrequency (RF) Generator SystemStryker Instruments20250—