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510(k) Data Aggregation

    K Number
    K243821
    Device Name
    i-Cut
    Manufacturer
    A.M.I. Agency for Medical Innovations GmbH
    Date Cleared
    2025-04-25

    (134 days)

    Product Code
    HET
    Regulation Number
    884.1720
    Why did this record match?
    Applicant Name (Manufacturer) :

    A.M.I. Agency for Medical Innovations GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The i-Cut system is indicated for morcellating and extracting tissue in laparoscopic, gynecologic surgical procedures.
    Device Description
    The i-Cut is a single use laparoscopic power morcellator. It is provided sterile. The i-Cut consists of a rotating cutting tube with a trocar that provides protection against the cutting blade when locked in the "CLOSED" position. The device comes with an obturator for placement into the patient's body and a locking clip that keeps the trocar in the "closed" position during insertion. The activation button must be pressed to cut tissue. The lumen of the device is designed for use with a standard grasper or Tenaculum forceps with a diameter between 10 to 14 mm. The i-Cut is designed to be used with surgical instruments of diameters between 10 to 14 mm. The lumen is fitted with a silicone valve to prevent gas loss during use of the device. The i-Cut is electrically operated by a DC Motor which is powered by a 24V AC/DC mains adapter. The non-sterile i-Cut Power Supply with power cord is supplied separately to power the device.
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