510(k) Report

Devices descending from K082643

9 later devices reach 3.5 MM Side Effect Electrode with Integrated Handpiece, Model 227301, 3.5 MM… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140896Vapr Arctic Suction ElectrodeDepuy Mitek, A Johnson & Johnson Company20140—
+1K120095Side Effect with Hand Controls, Hook Electrode with Hand Controls, 2.3 Wedge Electrode…Depuy Mitek, A Johnson & Johnson Company20120—
+1K100638Vapr Vue Radiofrequency System ,Model 225024, VPR Vue Wireless Footswitch, Model 227214Depuy Mitek, A Johnson & Johnson Company20108—
+2K173740Reprocessed DePuy Mitek Ablation WandRenovo, Inc.20180—
+2K152777Bovie Disposable Bipolar AblatorBovie Medical Corporation201632
+2K143475VAPR Tripolar Suction ElectrodeDepuy Mitek201501
+3K231126Eblator DeviceE Surgical, LLC20231—
+3K161558Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm…Bovie Medical Corporation201623
+4K251899E BlatorNew Deantronics Taiwan, Ltd.20250—