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

    COALESCENT SURGICAL U-CLIP

    K Number: K013664 · Decision Jan 24, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    2
    Applicant Total
    9
    Review Days
    79

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    Basic Information

    Device Name
    COALESCENT SURGICAL U-CLIP
    K Number
    K013664
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Coalescent Surgical
    Date Received
    November 6, 2001
    Decision Date
    January 24, 2002
    Product Code
    NCA
    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
    NCA Clip, Implantable, For Coronary Artery Bypass Graft (Cabg)

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    Other Clearances by Coalescent Surgical

    K Number Device Name
    K040821 COALESCENT SURGICAL U-CLIP AND ACCESSORIES
    K031623 MODIFICATION TO COALESCENT SURGICAL U-CLIP AND ACCESSORIES
    K024366 COALESCENT SURGICAL U-CLIP AND ACCESSORIES
    K023125 COALESCENT U-CLIP- AND ACCESSORIES
    K021407 COALESCENT SURGICAL U-CLIP - OR OTHER TBD AND ACCESSORIES
    K012317 COALESCENT SURGICAL U-CLIP
    K003958 COALESCENT U-CLIP DELIVERY AND DISPOSAL DEVICE
    K994160 COALESCENT SURGICAL SUTURED-CLIP