Device typeElectrosurgical system: An assembly of devices intended to generate, and apply radio-frequency (RF) alternating current to soft tissues for cutting and coagulation during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues (i.e., not a radio-frequency ablation system). The assembly includes a mains electricity-powered (AC-powered) RF generator with monitoring functions/controls, connection cables, a handpiece, and electrodes to apply the energy to the surgical site. Tissue resistance to the electrical current creates the heat as the current travels through the body between electrodes; it is not intended for inert gas-enhanced electrosurgery.
FDA categoryApparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered
Device IDB560C20200
Catalog numberC2020
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information