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

    KIRWAN MODEL 28 1000 BIPOLAR COAGULATOR

    K Number: K971341 · Decision May 22, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    18
    Review Days
    42

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    Basic Information

    Device Name
    KIRWAN MODEL 28 1000 BIPOLAR COAGULATOR
    K Number
    K971341
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kirwan Surgical Products, Inc.
    Date Received
    April 10, 1997
    Decision Date
    May 22, 1997
    Product Code
    GEI
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GEI Electrosurgical, Cutting & Coagulation & Accessories

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    Other Clearances by Kirwan Surgical Products, Inc.

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    K060915 KIRWAN L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE ANEURYSM CLIPS AND APPLIERS
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    K023482 AURA 20 BIPOLAR ELECTROSURGICAL COAGULATOR, MODEL 26-2500
    K992218 DISPOSABLE IRRIGATION BIPOLAR CORD ASSEMBLY FOR MALIS SYSTEM CMC-II, MODEL 10-4601
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    K965241 BIPOLAR SUCTION COAGULATOR
    K962678 BIPOLAR PENCIL COAGULATOR
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