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510(k) Data Aggregation

    K Number
    K964379
    Device Name
    KSEA PUNCTURE CANNULA
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Date Cleared
    1997-01-29

    (86 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 KSEA Puncture Cannula are intended for use by qualified surgeons or physicians to puncture and drain a cyst or other structure within the surgical site.

    Device Description

    The KSEA Puncture Cannula reusable surgical devices provided to the end-user in a non-sterile condition. The KSEA Puncture Cannula are part of the KSEA "Irrigation and Suction System" and are intended to be used with KSEA Irrigation and Suction System Handpiece. The body contact materials are surgical grade stainless steel.

    AI/ML Overview

    I am sorry, but based on the text you provided, there is no information about acceptance criteria or a study proving device performance for the KSEA Puncture Cannula. The document is a 510(k) summary and primarily focuses on device identification, indications for use, device description, and substantial equivalence to predicate devices. It does not contain the detailed study information you are requesting.

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