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510(k) Data Aggregation

    K Number
    K011573
    Device Name
    HYALURONIDASE IN HTF MEDIUM; HYALURONIDASE IN EBSS MEDIUM
    Manufacturer
    CONCEPTION TECHNOLOGIES
    Date Cleared
    2001-07-02

    (42 days)

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

    HYALURONIDASE IN HTF MEDIUM; HYALURONIDASE IN EBSS MEDIUM

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

    Hyaluronidase in HTF Medium is used prior to intracytoplasmic sperm injections (ICSI) procedures to digest the hyaluronic acid holding the cumulus cells together to permit easy handling of the oocytes.

    Device Description

    Hyaluronidase in HTF Medium; Hyaluronidase in EBSS Medium

    AI/ML Overview

    This document is a 510(k) premarket notification from the FDA, specifically approving a device called "Hyaluronidase in HTF Medium" for use in intracytoplasmic sperm injection (ICSI) procedures. It does not contain information about acceptance criteria, study details, or device performance metrics like accuracy, sensitivity, or specificity.

    The document is primarily an approval letter and a statement of the device's intended use. It confirms that the device is "substantially equivalent" to legally marketed predicate devices.

    Therefore, I cannot provide the requested information from this document. To fulfill your request, I would need a different type of document, such as a clinical study report, a scientific paper, or a detailed device performance specification sheet.

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