BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SYDNEY IVF EMBRYO BIOPSY MEDIUM

    K Number: K023850 · Decision Jan 22, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    258
    Applicant Total
    43
    Review Days
    64

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    Basic Information

    Device Name
    SYDNEY IVF EMBRYO BIOPSY MEDIUM
    K Number
    K023850
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.6180
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cook Ob/Gyn
    Date Received
    November 19, 2002
    Decision Date
    January 22, 2003
    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 Cook Ob/Gyn

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    K013597 TAMPONADE UTERINE BALLOON CATHETER SET
    K002385 COOK IVF FOLLICLE FLUSHING BUFFER, COOK IVF OOCYTE WASH BUFFER, COOK IVF FERTILIZATION MEDIUM, COOK IVF CLEAVAGE MEDIUM,
    K002383 COOK IVF SPERM BUFFER, COOK IVF SPERM MEDIUM, AND COOK IVF SPERM GRADIENT KIT
    K983595 TRANSMYOMETRIAL EMBRYO TRANSFER SET
    K983596 INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES, ASSISTED HATCHING
    K983642 COOK MINI-INCUBATOR
    K983593 OVUM PICK-UP ASPIRATION NEEDLES
    K983591 INTRATUBAL TRANSFER SETS
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