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

    ECHOTIP(R) ULTRA FIDUCIAL NEEDLE

    K Number: K111895 · Decision Apr 27, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    102
    Registration Numbers
    102
    Same Product Code
    109
    Applicant Total
    7
    Review Days
    297

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    Basic Information

    Device Name
    ECHOTIP(R) ULTRA FIDUCIAL NEEDLE
    K Number
    K111895
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Wilson-Cook Medical Inc./Cook Endoscopy
    Date Received
    July 5, 2011
    Decision Date
    April 27, 2012
    Product Code
    NEU
    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
    NEU Marker, Radiographic, Implantable

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