f00b7489-7cdc-4218-91ae-708217fd1798NewPublished12023-11-012023-10-24In Commercial Distribution08809295147443PrimaryGS1V-TipBMDT 1715B690514869RF Medical Co.,Ltd.1falsefalsefalsefalsefalsetruefalsetruefalsetruefalsefalsefalseLabeling does not contain MRI Safety InformationtruefalseK23276300061933Percutaneous radio-frequency ablation probe, tumour-ablation, monopolarA semi-flexible, hand-held surgical instrument intended to be percutaneously introduced via a dedicated cannula [under computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound (US) guidance] to deliver radio-frequency current in a monopolar configuration from a system generator to coagulate/ablate tissues (excluding the CNS and heart) for the treatment of tumours (e.g., in the liver); in addition to percutaneous access it might also be intended for laparoscopic and/or open surgical use. It includes one or more distal monopolar electrode(s) which may include temperature-sensing elements; the introduction cannula may be included. This is a single-use device.falseActiveGEIElectrosurgical, Cutting & Coagulation & AccessoriesJOSElectrode, Electrosurgicaltruefalse