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

    ADVANCED SURGICAL 19 & 20 GAUGE DISP. SCLERAL PLUG

    K Number: K880953 · Decision May 13, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    9
    Applicant Total
    64
    Review Days
    67

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    Basic Information

    Device Name
    ADVANCED SURGICAL 19 & 20 GAUGE DISP. SCLERAL PLUG
    K Number
    K880953
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4155
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Advanced Surgical Products, Inc.
    Date Received
    March 7, 1988
    Decision Date
    May 13, 1988
    Product Code
    LXP
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LXP Plug, Scleral

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