Device Dossier

Electrosurgical system generator, general-purpose

Device Dossier for Electrosurgical system generator, general-purpose (Electrosurgical system generator, general-purpose, Class IIb, sponsor Compliance…

Intended purpose

ArtiSeal Generator is a high-frequency electrosurgical device used in conjunction with disposable hand-controlled electrosurgical instruments, known as ArtiSeal Instruments. It provides radiofrequency (RF) energy to ligate vessels and tissue bundles. This energy platform automatically detects the connected instrument and immediately performs safety and diagnostic functions for the instrument. It is indicated for use in general surgery.