Device Dossier
Electrosurgical system, general-purpose
Device Dossier for Electrosurgical system, general-purpose (Electrosurgical system, general-purpose, Class IIb, sponsor FOTEK). ARTG record, intended…
- GMDN category: Electrosurgical system, general-purpose
Intended purpose
Electrosurgical systems "FOTEK" is 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. 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. “FOTEK” generators and accessories are compatible with electrosurgical accessories and generators of all modern manufactures.