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

    Giftlife® Single-Step Medium Plus

    K Number: K242968 · Decision Nov 22, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    258
    Applicant Total
    7
    Review Days
    57

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    Basic Information

    Device Name
    Giftlife® Single-Step Medium Plus
    K Number
    K242968
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.6180
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Gimbo Medical Technology Shenzhen Co., Ltd.
    Date Received
    September 26, 2024
    Decision Date
    November 22, 2024
    Product Code
    MQL
    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
    MQL Media, Reproductive

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    Other Clearances by Gimbo Medical Technology Shenzhen Co., Ltd.

    K Number Device Name
    K253121 Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval Needle
    K242043 Sperm Freezing Medium
    K240002 G-Vitri™ Vitrification Straw
    K240149 Giftlife™ Fertilization Medium; Giftlife™ Cleavage Medium; Giftlife™ Blastocyst Medium; Giftlife™ Single Step Medium
    K234023 Oocyte Flushing & Retrieval Medium; Gamete Buffer
    K232942 G-Vitri™ Vitrification Freeze Media; G-Vitri™ Vitrification Thawing Media