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510(k) Data Aggregation

    K Number
    K012153
    Device Name
    LOWSLEY SUPRAPUBIC TRACTOR
    Manufacturer
    CIRCON VIDEO
    Date Cleared
    2001-09-19

    (70 days)

    Product Code
    KOB
    Regulation Number
    876.5090
    Type
    Traditional
    Panel
    Gastroenterology-Urology (GU)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    LOWSLEY SUPRAPUBIC TRACTOR

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

    The intended use for the Circon Lowsley™ Suprapubic Tractor is for conventional Open Perineal Prostatectomy Procedures and for Suprapubic Catheter Placement.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter for the Lowsley™ Suprapubic Tractor. It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.

    The document is a regulatory approval notice, indicating that the device has been deemed substantially equivalent to a predicate device and can therefore be marketed. It does not include technical study details.

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