BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle

    K Number: K232163 · Decision Feb 22, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    32
    Applicant Total
    2
    Review Days
    216

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    Basic Information

    Device Name
    Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle
    K Number
    K232163
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.6100
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zhejiang Horizon Medical Technology Co., Ltd.
    Date Received
    July 21, 2023
    Decision Date
    February 22, 2024
    Product Code
    MQE
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MQE Needle, Assisted Reproduction

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    Other Clearances by Zhejiang Horizon Medical Technology Co., Ltd.

    K Number Device Name
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