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510(k) Data Aggregation

    K Number
    K963872
    Device Name
    FEMRX MORCELLATOR SYSTEM
    Manufacturer
    GYNECARE INNOVATION CENTER
    Date Cleared
    1997-01-17

    (113 days)

    Product Code
    HET
    Regulation Number
    884.1720
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K954648,K962506
    Why did this record match?
    Reference Devices :

    K954648, K962506

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Not Found

    Device Description

    The FemRx™ Morcellator System is virtually identical to the currently marketed Karl Storz STEINER™ Morcellator in terms of its tissue cutting and extraction mechanism. Both devices utilize a separate motor drive box and flexible drive a rotating cutting blade, internal to a cylindrical housing, used to cut or core tissue as it is drawn up through the central lumen of the device by the use of standard forceps.

    The principle difference between the FemRx™ Morcellator and the Storz device is that the FemRx device incorporates a fixed cylinder inside the rotating cutter (see figure below). The fixed (non rotating) cylinder located on the inside of the cutter is designed to reduce the torsional or rotational force applied to the cored tissue fragments as they are pulled up through the central lumen of the FemRx™ device.

    The FemRx™ Morcellator System also differs from the Storz device in that it is disposable and utilizes the Motor Drive Unit (MDU) that has been previously cleared as part of the FemRx™ ores STARTM and TORSTAR™ Hysteroscopic and Urological Resectosocipic Systems [510(k) numbers K954648 and K962506].

    All tissue contacting materials are standard medical grade and non-toxic.

    AI/ML Overview

    Based on the provided text, it appears that the FemRx™ Morcellator is being compared to the Karl Storz STEINER™ Morcellator, highlighting the FemRx's design difference (fixed internal cylinder) and disposability, and its use of a previously cleared motor drive unit.

    However, the provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert involvement, or any of the other specific details requested for a comprehensive study description.

    Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, or details about the study that proves the device meets specific criteria, as this information is entirely absent from the provided "Input" text.

    If you can provide a different input that includes such study details, I would be happy to process it accordingly.

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