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

    ORBITAL TISSUE EXPANDER (OTE)

    K Number: K060151 · Decision Aug 8, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    1
    Applicant Total
    3
    Review Days
    200

    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
    ORBITAL TISSUE EXPANDER (OTE)
    K Number
    K060151
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.3320
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Innovia, LLC
    Date Received
    January 20, 2006
    Decision Date
    August 8, 2006
    Product Code
    NFM
    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
    NFM Expander, Tissue, Orbital

    Similar 510(k) Clearances

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

    OSMED TISSUE EXPANDER

    FDA 510(k)
    FDA Class 2 ·Ophthalmic
    View all

    Other Clearances by Innovia, LLC

    K Number Device Name
    K093783 INNOVIA INNOPORT LAPAROSCOPIC ACCESS PORT
    K090677 INNOPORT LAPAROSCOPIC ACCESS DEVICE