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510(k) Data Aggregation

    K Number
    K132651
    Device Name
    ITCLAMP 50
    Date Cleared
    2013-10-28

    (63 days)

    Product Code
    Regulation Number
    870.4450
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    Matched: '882.4150'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The iTClamp50 is a trauma clamp device for the temporary control of severe bleeding in the extremities, axilla, inguinal areas and scalp.
    Device Description
    The iTClamp™50 is a clamp device that quickly controls critical bleeding by closing the skin to create a temporary, contained hematoma until surgical repair. The iTClamp50 is a selflocking surgical clamp with suture needles that penetrate the skin to evert the skin/scalp edges (similar to sutures or staples) between pressure bars of the device and anchor it to the skin to reduce slippage and leakage. Pressure is evenly distributed across the bars, which seal the skin over a wound. An adjustable locking mechanism increases or decreases pressure across the wound to achieve a fluid tight seal. The iTClamp controls bleeding by sealing the skin/scalp closed to apply direct pressure to the cut edges of the skin/scalp and create a temporary pool of blood (hematoma) under pressure. This permits formation of a stable clot until the patient can receive medical care and/or surgical repair. The device is provided sterile and is for single use. The iTClamp consists of the following components: 1) Suture needles 2) Plastic shell 3) Locking mechanism 4) Lock release mechanism
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    K Number
    K050044
    Device Name
    MEDTRONIC CLIP GUN KIT
    Date Cleared
    2005-02-07

    (28 days)

    Product Code
    Regulation Number
    882.4150
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    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
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    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
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    Matched: '882.4150'

    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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