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

    COOK ASPIRATION UNIT

    K Number: K930900 · Decision Jul 22, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    76
    Applicant Total
    43
    Review Days
    150

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    Basic Information

    Device Name
    COOK ASPIRATION UNIT
    K Number
    K930900
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4780
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cook Ob/Gyn
    Date Received
    February 22, 1993
    Decision Date
    July 22, 1993
    Product Code
    JCX
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered

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    Other Clearances by Cook Ob/Gyn

    K Number Device Name
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    K030441 SYDNEY IVF BLASTOCYST CRYOPRESERVATION KIT AND SYDNEY IVF BLASTOCYST THAW KIT
    K023850 SYDNEY IVF EMBRYO BIOPSY MEDIUM
    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
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