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510(k) Data Aggregation

    K Number
    K971303
    Device Name
    INSTEAD, SOFTCUP
    Manufacturer
    ULTRAFEM, INC.
    Date Cleared
    1997-06-06

    (59 days)

    Product Code
    HHE
    Regulation Number
    884.5400
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    INSTEAD, SOFTCUP

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

    For use as a form of feminine protection, commonly employed to collect blood, help prevent leakage and to prevent staining and spotting of clothing.

    Device Description

    Not Found

    AI/ML Overview

    While the provided text is an FDA 510(k) clearance letter for the INSTEAD Softcup, it does not contain the detailed clinical study information required to answer your specific questions about acceptance criteria and study findings.

    FDA 510(k) clearances determine substantial equivalence to a predicate device, which often relies on demonstrating similar performance characteristics, but the submission itself is a separate document that would contain the detailed study results. The letter only states that the device is "substantially equivalent" to previously marketed devices.

    Therefore, I cannot provide the requested information from the given text.

    To answer your request, I would need to analyze the underlying 510(k) summary document or the full 510(k) submission, which is not included in the provided snippets.

    If you were to provide a document that describes the clinical performance and testing conducted for the INSTEAD Softcup, I could attempt to extract the requested information.

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