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510(k) Data Aggregation

    K Number
    K971649
    Device Name
    KSEA ARTHROPUMP PLUS
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Date Cleared
    1997-10-29

    (176 days)

    Product Code
    HRX
    Regulation Number
    888.1100
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    KSEA ARTHROPUMP PLUS

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

    The Karl Storz Arthropump Plus system is designed to provide irrigation and aspiration of the surgical site during arthroscopic surgical procedures.
    These instruments are intended for use by qualified surgeons and provide irrigation/aspiration to the surgical site during arthroscopic surgical procedures.

    Device Description

    The Karl Storz Arthropump Plus and accessories is a roller type irrigation/aspiration pump with user adjustable irrigation flow rate, irrigation pressure, and aspiration suction underpressure.

    AI/ML Overview

    This 510(k) summary for the Karl Storz Arthropump Plus system states that it is substantially equivalent to predicate devices. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a regulatory approval and not a detailed performance study.

    Therefore, I cannot provide the requested information based on the input text. The input does not describe a study or acceptance criteria for device performance.

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