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510(k) Data Aggregation

    K Number
    K242043
    Device Name
    Sperm Freezing Medium
    Manufacturer
    Gimbo Medical Technology Shenzhen Co., Ltd.
    Date Cleared
    2025-01-08

    (180 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    Gimbo Medical Technology Shenzhen Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sperm Freezing Medium is intended for the cryopreservation of human semen samples to sperm samples during cryopreservation and thawing prior to use in assisted reproductive technology procedures.
    Device Description
    Not Found
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    K Number
    K242968
    Device Name
    Giftlife® Single-Step Medium Plus
    Manufacturer
    Gimbo Medical Technology Shenzhen Co., Ltd.
    Date Cleared
    2024-11-22

    (57 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    Gimbo Medical Technology Shenzhen Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Giftlife Single-Step Medium Plus is used for culture of embryos from fertilization to the blastocyst stage.
    Device Description
    Not Found
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    K Number
    K240002
    Device Name
    G-Vitri™ Vitrification Straw
    Manufacturer
    Gimbo Medical Technology Shenzhen Co., Ltd.
    Date Cleared
    2024-06-14

    (164 days)

    Product Code
    MQK, MOK
    Regulation Number
    884.6160
    Why did this record match?
    Applicant Name (Manufacturer) :

    Gimbo Medical Technology Shenzhen Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The G-Vitri™ Vitrification Straw is a cryopreservation storage device intended for use in vitrification procedures to contain and maintain human oocytes (MII), 4-8 cell embryos, and blastocyst stage embryos.
    Device Description
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    K Number
    K240149
    Device Name
    Giftlife™ Fertilization Medium; Giftlife™ Cleavage Medium; Giftlife™ Blastocyst Medium; Giftlife™ Single Step Medium
    Manufacturer
    Gimbo Medical Technology Shenzhen Co., Ltd.
    Date Cleared
    2024-06-13

    (146 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    Gimbo Medical Technology Shenzhen Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Giftlife Fertilization Medium is intended for use during in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI) procedures and culture to the two pronuclei (zygote) stage of development. Giftlife Cleavage Medium is intended for use during in vitro fertilization (IVF) for culture of embryos from pronucleate stage to day 2 or day 3. This medium is not intended for transferring embryos to the uterine cavity. Giftlife Blastocyst Medium is intended for use during in vitro fertilization (IVF) for culture of embryos from day 3 to the blastocyst stage. This medium is not intended for transferring embryos to the uterine cavity. Giftlife Single Step Medium is used for culture of embryos from fertilization to the blastocyst stage.
    Device Description
    Not Found
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    K Number
    K234023
    Device Name
    Oocyte Flushing & Retrieval Medium; Gamete Buffer
    Manufacturer
    Gimbo Medical Technology Shenzhen Co., Ltd.
    Date Cleared
    2024-05-10

    (142 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    Gimbo Medical Technology Shenzhen Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Oocyte Flushing & Retrieval Medium is intended for use during and oocyte collection procedures for use in in vitro fertilization procedures. Gamete Buffer is indicated for use in short-term handling gametes and embryos, including washing and intracytoplasmic sperm injection (ICSI).
    Device Description
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    K Number
    K232942
    Device Name
    G-Vitri™ Vitrification Freeze Media; G-Vitri™ Vitrification Thawing Media
    Manufacturer
    Gimbo Medical Technology Shenzhen Co., Ltd.
    Date Cleared
    2024-01-30

    (132 days)

    Product Code
    MQL, MOL
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    Gimbo Medical Technology Shenzhen Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The G-Vitri™ Vitrification Freeze Media is indicated for use in the vitrification of occytes (MI), pronuclear (PN) zygotes through day 3 cleavage stage embryos, and blastocyst stage embryos. The G-Vitri™ Vitrification Thawing Media is indicated for use in the thawing of vitrified oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos, and blastocyst stage embryos.
    Device Description
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