510(k) Report

Devices descending from K032132

44 later devices reach Tissuelink Floating Ball Model 23-201-1 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052859Aquamantys Pump Generator SystemTissuelink Medical, Inc.2005241
+1K050459Atricure Isolator Transpolar PenAtriCure, Inc.2005181
+2K210423Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0 Hemostasis WandArthroCare Corporation20212—
+2K143175AEx Generator; PlasmaBlade TMedtronic Advanced Energy20141—
+2K132974Aquamantys 2.3 Bipolar Sealer, Evs 4.0 Epidural Vein Sealer, Mini Evs 3.4 Epidural Vein…Medtronic Advanced Energy, LLC20134—
+2K130110Meddusa Bipolar SystemElliquence, LLC20134—
+2K111732Aquamantys SBS 5.0 Sheated Biopolar SealerSalient Surgical Technologies, Inc.20115—
+2K111285Aquamantys 3 Pump Generator, Bipolar Sealer, Bipolar Sealer with CuttingSalient Surgical Technologies, Inc.201131
+2K101057Aquamantys Double Cone Bipolar Sealer Model: 23-310-1Salient Surgical Technologies20113—
+2K100501Multifunctional Linear PenAtriCure, Inc.20109—
+2K092149Boss Coagulation Device, Model BOSS1215, Boss Coagulation Device, Angled Access, Model…Bovie Medical20100—
+2K073605Atricure Coolrail Linear PenAtriCure, Inc.200813—
+2K073495Tissuelink Aquamantys Malleable Bipolar Sealer with LightTissuelink Medical, Inc.20082—
+2K063639Aquamantys SS4.0 Bipolar Sealer, Model 23-121-1Tissuelink Medical, Inc.20077—
+2K061593Atricure Isolator Transpolar Pen System, Models ASU2, MAX1, MAX2 and ASB1AtriCure, Inc.2006131
+3K232290INTELLIO SHIFT SystemArthroCare Corporation20230—
+3K230914ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System…ArthroCare Corporation20230—
+3K211203Green OR Reprocessed Aquamantys Bipolar SealerGreen Or, LLC20220—
+3K192125Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear PenAtriCure, Inc.20191—
+3K190336Soniquence Bipolar ElectrodesSoniquence, LLC20193—
+3K181071SIRA RFA Electrosurgical DeviceInnoblative Designs, Inc.20191—
+3K170381Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex MiniMedtronic Advanced Energy20170—
+3K170610PlasmaBlade TMedtronic Advanced Energy20170—
+3K130521Isolator Linear PenAtriCure, Inc.20133—
+3K123201Aquamantys Endo DBS 8.7 Dissecting Bipolar SealerMedtronic Advanced Energy, LLC20130—
+3K122611Coolrail Linear Pen Model McriAtriCure, Inc.20123—
+3K121290AQUAMANTRYS3 BSC 9.1SMedtronic, Inc.20120—
+3K120537AQUAMANTYS3 9.5 XL Bipolar SealerMedtronic, Inc.20121—
+3K113475Estech Cobra Adhere XL 2 Surgical SystemEndoscopic Technologies, Inc. D/B/A Estech201245
+3K070288Cardioblate Monopolar Pen, 60813, Cardioblate Monopolar XL, 60814Medtronic Vascular20072—
+4K232947SIRA™ RFA Electrosurgical DeviceInnoblative Designs, Inc.20230—
+4K221358Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail® Linear…AtriCure, Inc.20220—
+4K211946Soniquence Reusable Bipolar CableSoniquence, LLC20210—
+4K202558Ellusa Bipolar WandsEllusa, LLC20201—
+4K190151COBRA Fusion Ablation SystemAtriCure, Inc.20190—
+4K183065Coolrail Linear PenAtriCure, Inc.20182—
+4K163408Isolator Multifunctional Linear PenAtriCure, Inc.20172—
+4K120857Epi-Sense Guided Coagulation Device with VisitraxNcontact Surgical, Inc.20122—
+4K090721Cardioblate Maps Surgical Mapping, Ablation, Pacing and Sensing Device, Model 49205Medtronic20091—
+5K222429Ellusa Reusable Bipolar CableEllusa, LLC20220—
+5K190587Coolrail Linear PenAtriCure, Inc.20191—
+5K142084Epi-Sense Guided Coagulation Device with VisitraxNcontact Surgical, Inc.201411
+5K121451Cardioblate Maps Surgical Mapping, Ablation, Pacing , and Sensing DeviceMedtronic, Inc.20120—
+6K193162EPi-Sense Guided Coagulation System with VisiTraxAtriCure, Inc.20190—