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510(k) Data Aggregation

    K Number
    K130087
    Device Name
    PANPAC WORD/BARTHOLIN CATHETER
    Manufacturer
    Panpac Medical Corporation
    Date Cleared
    2014-01-10

    (361 days)

    Product Code
    KNA
    Regulation Number
    884.4530
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PANPAC WORD/BARTHOLIN CATHETER

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

    The Panpac Word/ Bartholin Catheter is used for the treatment of abscesses and cysts of the Bartholin gland.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided document, there is no information about acceptance criteria, device performance, or any studies related to the Panpac Word/Bartholin Catheter.

    The document is a 510(k) premarket notification letter from the FDA to Panpac Medical Corporation, informing them of the substantial equivalence determination for their device. It focuses on regulatory compliance, outlining general controls provisions and other applicable regulations. It also includes the "Indications for Use" statement for the device.

    Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

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