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

    KIRWAN L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE ANEURYSM CLIPS AND APPLIERS

    K Number: K060915 · Decision Apr 17, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    35
    Applicant Total
    18
    Review Days
    378

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    Basic Information

    Device Name
    KIRWAN L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE ANEURYSM CLIPS AND APPLIERS
    K Number
    K060915
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5200
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kirwan Surgical Products, Inc.
    Date Received
    April 4, 2006
    Decision Date
    April 17, 2007
    Product Code
    HCH
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HCH Clip, Aneurysm

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    Other Clearances by Kirwan Surgical Products, Inc.

    K Number Device Name
    K100912 DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULATOR PROBE, BIPOLAR SIDE BY SIDE
    K070360 KIRWAN DISPOSABLE 23KHZ MANIFOLD TUBING, 40-3600, & 36KHZ MANIFOLD TUBING, 40-3601
    K062659 KIRWAN DISPOSABLE BATTERY-POWERED CAUTERY, MODEL 41-61XX SERIES
    K052203 AURA 70 WATT BIPOLAR ELECTROSURGICAL COAGULATORS, MODELS 28-2000 AND 28-2600
    K023482 AURA 20 BIPOLAR ELECTROSURGICAL COAGULATOR, MODEL 26-2500
    K992218 DISPOSABLE IRRIGATION BIPOLAR CORD ASSEMBLY FOR MALIS SYSTEM CMC-II, MODEL 10-4601
    K982176 KIRWAN SURGICAL PRODUCTS, INC. MODEL 28 1500 ELECTROSURGERY GENERATOR
    K971341 KIRWAN MODEL 28 1000 BIPOLAR COAGULATOR
    K965241 BIPOLAR SUCTION COAGULATOR
    K962678 BIPOLAR PENCIL COAGULATOR
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