67f192b1-c833-42e6-9892-5f1396a43673NewPublished12025-09-152025-09-05In Commercial Distribution08809295148952PrimaryGS1BIG-TIP™BT+ 1525B690514869RF Medical Co.,Ltd.1falsefalsefalsefalsefalsetruefalsetruetruetruefalsefalsefalseLabeling does not contain MRI Safety InformationtruefalseK22127700061933Percutaneous 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 & Accessoriestruefalse