510(k) Report

Devices descending from K091310

11 later devices reach Ablation Instrument, Model 1635; Ablation Multiplex Catheter, Model 1682 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142480OsteoCool V-2 RF Ablation SystemBaylis Medical Company, Inc.20159—
+1K111523Osteocool (TM) RF Ablation SystemBaylis Medical Co., Inc.20120—
+2K152057OsteoCool V-3 RF Ablation SystemBaylis Medical Company, Inc.20158—
+3K161949OsteoCool V-3 RF Ablation SystemBaylis Medical Company, Inc.20177—
+4K192406AveCure BT Microwave Ablation SystemMedwaves, Inc.20200—
+4K182497OsteoCool RF Ablation SystemMedtronic Sofamor Danek USA, Inc.20195—
+5K233830OsteoCool™ 2.0 RF Ablation SystemMedtronic Sofamor Danek USA, Inc.20241—
+5K223303Spinery™ RF Ablation SystemAxon Spine Medical System20230—
+5K221074OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion DeviceStryker Corporation20222—
+6K253656OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K250327OptaBlate Radiofrequency (RF) Generator SystemStryker Instruments20250—