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510(k) Data Aggregation

    K Number
    K244029
    Date Cleared
    2025-09-24

    (268 days)

    Product Code
    Regulation Number
    876.1500
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ROBOPERA is intended to hold and lift the tissue and mucosal membrane within the esophagus, stomach, colon, and rectum of the gastrointestinal tract, excluding the small intestine, during endoscopic surgical procedures. It is intended to be used by trained physicians in a hospital.

    Device Description

    This product consists of a driving unit, an instrument, and a controller. The forceps of the instrument are mounted on the outer tip of the endoscope, the cartridge is inserted into the driving unit, and the controller is mounted on the endoscope boot.

    The user can perform four operations (Grip, Wrist, Arm, Roll) of the instrument (Articulated Basic Gripper G), and three operations (Grip A, B, Arm, Roll) of the instrument (Articulated Dual Gripper G) through the controller.

    In this product, the power generated through the motor in the driving unit is transmitted to the forceps in a physical way through the instrument cartridge and cable, and the forceps can perform four movements: grip, wrist, arm, and roll using the transmitted force to catch and lift and fix the mucous membrane of the lesion during mucosal incision or resection using an endoscope. In addition, after mucosal incision and resection, it can play a role of assisting in clipping by catching and collecting a part of the mucous membrane.

    ROBOPERA Configurations:

    Model NameDescription
    ER-R-002Driver Unit + Instrument (Articulated Basic Gripper G)
    ER-R-003Driver Unit + Instrument (Articulated Dual Gripper G)
    AI/ML Overview

    N/A

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