BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SONI-LOK SCOPE STABILIZER

    K Number: K850122 · Decision Feb 21, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    38

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    Basic Information

    Device Name
    SONI-LOK SCOPE STABILIZER
    K Number
    K850122
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4160
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Med Surg Designs, Inc.
    Date Received
    January 14, 1985
    Decision Date
    February 21, 1985
    Product Code
    FXR
    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
    FXR Holder, Camera, Surgical

    Similar 510(k) Clearances

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

    TELEVISION CAMERA HOLDER FOR SURGERY

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    Other Clearances by Med Surg Designs, Inc.

    K Number Device Name
    K863639 ARTICULAR MOTION DEVICE (AMD4000)