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510(k) Data Aggregation

    K Number
    DEN190022
    Device Name
    Hominis Surgical System
    Date Cleared
    2021-02-26

    (681 days)

    Product Code
    Regulation Number
    878.4961
    Why did this record match?
    Applicant Name (Manufacturer) :

    Memic Innovative Surgery Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended 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 ●
    Device Description
    The Hominis Surgical System (see Figure 1) is a mountable electromechanical surgical system for transluminal approaches used in single-site benign hysterectomy and salpingo-oophorectomy surgical procedures through a transvaginal access point. The system consists of two (2) Hominis Arms, a Hominis Control Console, a Hominis Motor Units Assembly, and Hominis Surgical System Accessories (Hominis Sterile Drape, GYN Trocar Kit, Hominis System Cables, and Bed Fixation Kit). During clinical use, surgeons operate the Hominis Arms from the Hominis Control Console with a compatible and FDA-cleared third-party standard laparoscope (transumbilical) and visual guidance system.
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