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

    MICRON-SCOPE

    K Number: K853499 · Decision Sep 24, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    206
    Registration Numbers
    207
    Same Product Code
    53
    Applicant Total
    2
    Review Days
    35

    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
    MICRON-SCOPE
    K Number
    K853499
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4350
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Magnum Diamond, Inc.
    Date Received
    August 20, 1985
    Decision Date
    September 24, 1985
    Product Code
    HNN
    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
    HNN Knife, Ophthalmic

    Similar 510(k) Clearances

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

    CLEARCUT S SAFETY KNIFE

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    OPHTHALMIC KNIFE

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    RETRACTIVE INCISION MICROMETER (RIM) GUAGE

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    MVR/STILETTO BLADE 20GA. - P/N 1900

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    PRISMA DISPOSABLE MVR/STILETTO BLADE

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    OPHTHALMIC TIP & BLADE SCALPELS

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

    Other Clearances by Magnum Diamond, Inc.

    K Number Device Name
    K895752 DIAMOND BLADE SURGICAL KNIVES