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510(k) Data Aggregation

    K Number
    K050044
    Device Name
    MEDTRONIC CLIP GUN KIT
    Date Cleared
    2005-02-07

    (28 days)

    Product Code
    Regulation Number
    882.4150
    Why did this record match?
    Product Code :

    HBO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Medtronic Neurosurgery Clip Gun Raney-type clips provide hemostasis during cranial surgery by preventing arterial bleeding from small vessels of the skin and deeper vessels under the scalp.
    Device Description
    The Clip Gun Kit contains Raney-type clips intended to provide hemostasis during cranial surgery by preventing arterial bleeding from vessels under the scalp. The Clips are a non-implantable transient use device.
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    K Number
    K033660
    Device Name
    STORZ RANEY SCALP CLIP, MODEL 1-20-004-05
    Manufacturer
    Date Cleared
    2004-01-07

    (47 days)

    Product Code
    Regulation Number
    882.4150
    Why did this record match?
    Product Code :

    HBO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The STORZ Raney Scalp Clip is a device designed to stop bleeding during surgery on the scalp.
    Device Description
    Not Found
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    K Number
    K012219
    Device Name
    SCALPFIX CLIP SYSTEM
    Manufacturer
    Date Cleared
    2001-07-31

    (15 days)

    Product Code
    Regulation Number
    882.4150
    Why did this record match?
    Product Code :

    HBO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Aesculap's Scalpfix clip system is indicated for use in temporary hemostasis of the scalp edge.
    Device Description
    Aesculap's scalp clip gun (FF012R) is a hand held manual instrument. It is used in conjunction with Aesculap's scalp clip (FF013P) to insert sterile plastic scalp clips at the margin of scalp wounds during operations on the cranium. The gun consists of a handle, trigger, magazine lock, and a maqazine suspension pin. The scalp clips are used for temporary hemostasis of the opened scalp. It has proven useful to use plastic clips to ligate the scalp during trepanation or large exposures of relatively long duration, thereby avoiding bleeding at the wound margin. Aescular scalp clips are intended for single use only. They may not be resterilized. The scalp clips are packaged as 10 scalp clips per magazine in a box of 20 magazines.
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