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

    KIRWAN IRRIGATION/ASPIRATION HANDPIECE

    K Number: K930113 · Decision Feb 17, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    234
    Registration Numbers
    235
    Same Product Code
    76
    Applicant Total
    18
    Review Days
    402

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    Basic Information

    Device Name
    KIRWAN IRRIGATION/ASPIRATION HANDPIECE
    K Number
    K930113
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4350
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Kirwan Surgical Products, Inc.
    Date Received
    January 11, 1993
    Decision Date
    February 17, 1994
    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 Kirwan Surgical Products, Inc.

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    K052203 AURA 70 WATT BIPOLAR ELECTROSURGICAL COAGULATORS, MODELS 28-2000 AND 28-2600
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    K992218 DISPOSABLE IRRIGATION BIPOLAR CORD ASSEMBLY FOR MALIS SYSTEM CMC-II, MODEL 10-4601
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