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

    EK DELIVERY DEVICE

    K Number: K121579 · Decision Oct 3, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    4
    Applicant Total
    1
    Review Days
    126

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    EK DELIVERY DEVICE
    K Number
    K121579
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4300
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tdak Medical, Inc.
    Date Received
    May 30, 2012
    Decision Date
    October 3, 2012
    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

    Similar 510(k) Clearances

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

    EndoSerter-PL

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    NCI SPATULA

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    TRIMOTION INJECTOR

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    ENDOSERTER

    FDA 510(k)
    FDA Class 1 ·Ophthalmic
    View all