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

    THE NEW MCINTYRE I.A. HANDPIECE

    K Number: K854402 · Decision Dec 30, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    234
    Registration Numbers
    235
    Same Product Code
    76
    Applicant Total
    9
    Review Days
    60

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    Basic Information

    Device Name
    THE NEW MCINTYRE I.A. HANDPIECE
    K Number
    K854402
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4350
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Microsurgical Technology, Inc.
    Date Received
    October 31, 1985
    Decision Date
    December 30, 1985
    Product Code
    HMX
    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
    HMX Cannula, Ophthalmic

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    Other Clearances by Microsurgical Technology, Inc.

    K Number Device Name
    K953959 PHACO HANDPIECE FOR PHACO FRAGMENTATION MACHINES, PHACO SLEEVE FOR ATTACHMENT TO PHACO HANDPIECES
    K946194 WEE BAG O'MERCURY
    K943672 PHACO NEEDLES AND TIPS
    K942403 INFUSION CANNULA
    K934844 INTER TIP T
    K854401 THE NEW MOBILE TIP MCINTYRE CANNULA
    K853777 THE NEW MCINTYRE CANNULA
    K840442 STERILIZED DISPOS. CYSTOTOME