Device Dossier

Electrosurgical system generator, general-purpose

Device Dossier for Electrosurgical system generator, general-purpose (Electrosurgical system generator, general-purpose, Class IIb, sponsor Medtronic).…

Intended purpose

An electrosurgical generator that delivers radio-frequency (RF) energy to instruments indicated for cutting and coagulation of soft tissue and for delivery of RF energy concurrent with saline to instruments indicated for hemostatic sealing and coagulation of soft tissue and bone. It is intended for, but not limited to, General, Plastic and Reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, Gynecologic, Orthopaedic, Arthroscopic, Spinal and Neurological, Thoracic, and Open abdominal surgery procedures.

TGA Public Summary