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510(k) Data Aggregation

    K Number
    K030116
    Device Name
    ENHANCE-S PLUS H
    Manufacturer
    CONCEPTION TECHNOLOGY, INC.
    Date Cleared
    2003-02-12

    (30 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Type
    Special
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ENHANCE-S PLUS H

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

    Cell isolation media used for separation and purification of human sperm for assisted reproduction procedures.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any studies conducted on the "Enhance-S Plus" device.

    The document is a 510(k) premarket notification letter from the FDA, indicating that the device "Enhance-S Plus" has been determined to be substantially equivalent to legally marketed predicate devices. It discusses regulatory classifications, general controls, and responsibilities of the manufacturer. The "Indications for Use Statement" on the last page merely specifies the intended use of the device: "Cell isolation media used for separation and purification of human sperm for assisted reproduction procedures."

    Therefore, I cannot provide the requested information.

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