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

    14.5-16.0 FRENCH CUFFED CATHETER REMOVAL DEVICE, SYMMETRY SURGICAL SINGEL USE

    K Number: K122263 · Decision Sep 28, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    63

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    Basic Information

    Device Name
    14.5-16.0 FRENCH CUFFED CATHETER REMOVAL DEVICE, SYMMETRY SURGICAL SINGEL USE
    K Number
    K122263
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5970
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Symmetry Medical
    Date Received
    July 27, 2012
    Decision Date
    September 28, 2012
    Product Code
    ODY
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ODY Tunneled Catheter Remover

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (ODY), ordered by most recent decision date.

    TRANS-CATHETER EXTRACTOR

    FDA 510(k)
    FDA Class 2 ·General Hospital
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