Device typeElectrolytic-plasma electrosurgical system: An assembly of devices intended to use radio-frequency (RF) alternating current in a bipolar configuration to excite electrolytes within a solution (typically saline) to create a focused, charged plasma sphere for cutting and coagulation of soft tissues during an endoscopic or open surgical procedure. The assembly includes a mains electricity (AC-powered) RF generator with monitoring functions/controls, connection cables, a handpiece, and bipolar electrodes to apply the energy to the surgical site. It is not dedicated to focal ablation of specific tissues (i.e., not a radio-frequency ablation system) and is not intended for argon-enhanced electrosurgery.
FDA categoryInsufflator, Hysteroscopic, Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar
Device ID00850033976335
Catalog numberFG-PRIME25
AvailabilityPrescription
MRI safetyMR Unsafe