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

    Biopsy Forceps

    K Number: K170726 · Decision Jun 2, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    22
    Applicant Total
    2
    Review Days
    85

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    Basic Information

    Device Name
    Biopsy Forceps
    K Number
    K170726
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4075
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fehling Instruments GmbH & Co. KG
    Date Received
    March 9, 2017
    Decision Date
    June 2, 2017
    Product Code
    DWZ
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DWZ Device, Biopsy, Endomyocardial

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