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510(k) Data Aggregation

    K Number
    K955168
    Device Name
    SURGICAL CUTTER
    Manufacturer
    PROMEX, INC.
    Date Cleared
    1996-01-22

    (70 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SURGICAL CUTTER

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

    Not Found

    Device Description

    Surgical Cutter

    AI/ML Overview

    I am sorry, but the provided text from the FDA letter about device K955168 only addresses regulatory information and does not contain any details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as it pertains to the device's technical or clinical performance. The document is strictly a regulatory communication regarding substantial equivalence. Therefore, I cannot fulfill your request based on the given input.

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