BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent for Some Indications 🇺🇸 United States

    MAMMARY SIZER

    K Number: K961356 · Decision Sep 23, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    12
    Applicant Total
    14
    Review Days
    168

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    Basic Information

    Device Name
    MAMMARY SIZER
    K Number
    K961356
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    General Surgical Innovations
    Date Received
    April 8, 1996
    Decision Date
    September 23, 1996
    Product Code
    MRD
    Advisory Committee
    Unknown
    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
    MRD Mammary Sizer

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    Other Clearances by General Surgical Innovations

    K Number Device Name
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    K972109 SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER
    K970201 GSI CANNULA WITH INTRODUCER
    K962702 SPACEMAKER SERIAL SURGICAL BALLOON DISSECTOR, WITH CANNULA, WITH VISUALIZATION AND WITH VISUALIZATION AND CANNULA
    K952278 THE REUSABLE SPACEMAKER SURGICAL BALLOON DISSECTOR & CANNULA
    K951878 SPACEMAKER, II SURGICAL BALLOON DISSECTOR WITH AND WITHOUT A CANNULA
    K944418 THE SPACEMAKER AND THE SPACEMAKER II
    K944536 GSI KNOTMAKER
    K943671 GSI CANNULA REDUCER ACCESSORY
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