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

    SCLERAL PLUGS, 19 AND 20 GAUGE

    K Number: K990872 · Decision Jul 13, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    9
    Applicant Total
    2
    Review Days
    119

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    Basic Information

    Device Name
    SCLERAL PLUGS, 19 AND 20 GAUGE
    K Number
    K990872
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4155
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ophthalmic Consultants, Inc.
    Date Received
    March 16, 1999
    Decision Date
    July 13, 1999
    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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    Other Clearances by Ophthalmic Consultants, Inc.

    K Number Device Name
    K990292 I/A (IRRIGATION/ASPIRATION) PACK, POSTERIOR VITRECOMY PACK, ANTERIOR VIRECTOMY PACK, PHACOEMULSIFICATION PACK, ADMIINISN