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

    GY-RO SAFE

    K Number: K883785 · Decision Jan 5, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    4
    Applicant Total
    1
    Review Days
    120

    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
    GY-RO SAFE
    K Number
    K883785
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4070
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Gy-Ro Industry, Inc.
    Date Received
    September 7, 1988
    Decision Date
    January 5, 1989
    Product Code
    HOG
    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
    HOG Burr, Corneal, Battery-Powered

    Similar 510(k) Clearances

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

    AMOILS EPITHELIAL SCRUBBER

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    PALLIKARIS BRUSH

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    BURR, CORNEAL, BATTERY-POWERED

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    OPHTEC RUST RING REMOVER

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