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

    EndoSerter-PL

    K Number: K203586 · Decision Feb 2, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    4
    Applicant Total
    1
    Review Days
    421

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    Basic Information

    Device Name
    EndoSerter-PL
    K Number
    K203586
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4300
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Corneagen, Inc.
    Date Received
    December 8, 2020
    Decision Date
    February 2, 2022
    Product Code
    OTZ
    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
    OTZ Graft Insertion Instrument For Endothelial Keratoplasty

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