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    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    TEKNO-MEDICAL OBSTETRICAL FORCEPS

    K Number: K013747 · Decision Feb 11, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    9
    Applicant Total
    2
    Review Days
    90

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    Basic Information

    Device Name
    TEKNO-MEDICAL OBSTETRICAL FORCEPS
    K Number
    K013747
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    884.4400
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tekno Medical Optik-Chirurgie GmbH & Co.
    Date Received
    November 13, 2001
    Decision Date
    February 11, 2002
    Product Code
    HDA
    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
    HDA Forceps, Obstetrical

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    Other Clearances by Tekno Medical Optik-Chirurgie GmbH & Co.

    K Number Device Name
    K003717 INSTRUMENTS FOR LAPAROSCOPY 5 MM, 10 MM WITH COLOURED HANDLE, DETACHABLE ENDODCOPIC INSTRUMENTS 5 MM, 10MM (HANDLE, SHAF