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510(k) Data Aggregation

    K Number
    K962090
    Device Name
    KARL STORZ MODEL 203210 O1 UNIMAT PLUS
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Date Cleared
    1996-09-30

    (124 days)

    Product Code
    HET
    Regulation Number
    884.1720
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Karl Storz Unimat Plus system is designed to provide irrigation and aspiration of the surgical site during general, endoscopic and laparoscopic surgical procedures.

    Device Description

    The Karl Storz Unimat Plus and accessories is a membrane type irrigation/aspiration pump with fixed irrigation/aspiration flow rate of 3.5 liters/min. and a maximum irrigation pressure of 400 mmHg.

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any studies related to a medical device. The document is a 510(k) summary for the Karl Storz Unimat Plus, detailing its intended use and substantial equivalence to predicate devices, but lacks the specific data requested in your prompt.

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