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Indications for use: The Hominis® Surgical System is an endoscopic instrument control system that is intended to assist in the accurate control of the Hominis Arms® during single site, natural orifice laparoscopic-assisted transvaginal benign surgical procedures listed below. The Hominis® Surgical System is indicated for use in adult patients. It is intended to be used by trained physicians in an operating room environment. The representative uses of the Hominis® Surgical System are indicated for the following benign procedures: Total Benign Hysterectomy with Salpingo-Oophorectomy • Total Benign Hysterectomy with Salpingectomy • Total Benign Hysterectomy • Salpingectomy • Oophorectomy • Adnexectomy • Ovarian cyst removal. Caution: The safety and effectiveness of the Hominis® Surgical System was established only for the representative uses mentioned in the Indications for Use. The demonstration of safety and effectiveness for the representative specific procedures did not include evaluation of outcomes related to the treatment of cancer (overall survival, disease-free survival, local recurrence) or treatment of the patient’s underlying is ease/condition. Device usage in all surgical procedures should be guided by the clinical judgment of an adequately trained surgeon. The prescription-use symbol or “Caution: Federal law restricts this device to sale by or on the order of a physician.” For safety information, including risks, indications, and specific warnings and cautions related to the Hominis System please refer to the Hominis Surgical System Instructions for Use provided with your Hominis Surgical System.
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