Device Dossier
Tissue morcellation system handpiece
Device Dossier for Tissue morcellation system handpiece (Tissue morcellation system handpiece, Class IIb, sponsor Obex MedTech). ARTG record, intended…
- GMDN category: Tissue morcellation system handpiece
Intended purpose
The Espiner Morcell8OR is an electrically powered morcellator intended for the controlled cutting, coring, and extraction of revascularized uterine tissue during minimally invasive gynecologic procedures. The device is specifically designed for use during a laparoscopic hysterectomy and laparoscopic myomectomy procedure. It is to be operated by trained surgeons, competent in minimally invasive gynecologic surgery within appropriately equipped clinical environments.