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510(k) Data Aggregation

    K Number
    K101101
    Device Name
    MINI-TONG
    Manufacturer
    MINI LAP TECHNOLOGIES INC.
    Date Cleared
    2010-07-23

    (94 days)

    Product Code
    OCW
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    MINI LAP TECHNOLOGIES INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The devices are used for temporary grasping and clamping of soft tissue and small tubular structures during minimally invasive procedures.
    Device Description
    The MINI-TONG instruments are minimally invasive devices. Prior to insertion, the physician must depress the safety button and retract the instrument into the needle is inserted through the soft tissue under visualization. Once the needle has penetrated the soft tissue, the physician will advance the instrument into the body cavity using the handle. As the instrument advances, the instrument will open. The device includes a self-activating safety that prohibits the jaws from returning to their fully retracted position while in use. The devices are sterile disposable, single patient only. The devices were designed to hold pneumoperitoneum during use.
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    K Number
    K093449
    Device Name
    MINI LAP RETRACTORS
    Manufacturer
    MINI LAP TECHNOLOGIES INC.
    Date Cleared
    2010-02-12

    (99 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    MINI LAP TECHNOLOGIES INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MINI LAP Instruments are a family of minimally invasive devices with the means to penetrate soft tissue to access certain areas of the human anatomy. The devices are used to manipulate other soft internal tissues.
    Device Description
    The MINI LAP Instruments are a family of minimally invasive devices. The devices penetrate soft tissue to access certain areas of the human anatomy. The devices are used to manipulate other soft internal tissues. Prior to insertion, the physician must depress the safety button and retract the instrument into the needle. The needle is inserted through the soft tissue under visualization. Once the needle has penetrated the soft tissue, the physician will advance the instrument into the body cavity using the handle. As the instrument advances, the jaws of the instrument will open. The device includes a self-activating safety that prohibits the jaws from returning to their fully retracted position while in use, which acts as a blunt shield for the sharp needle tip. The device is provided in the following configurations: 250mm Length with Retractor Fan Clamp Type and 250mm Length with Retractor Rake Clamp Type. The devices are sterile disposable, single patient only. The devices were designed to hold pneumoperitoneum during use.
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    K Number
    K083754
    Device Name
    MINI LAP ELECTROCAUTERY INSTRUMENTS
    Manufacturer
    MINI LAP TECHNOLOGIES INC.
    Date Cleared
    2009-11-20

    (338 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    MINI LAP TECHNOLOGIES INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The devices are used to cut and cauterize soft tissue.
    Device Description
    Not Found
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    K Number
    K070352
    Device Name
    MINI LAP PEDIATRIC INSTRUMENTS WITH MEDUSA CLAMPING SYSTEM
    Manufacturer
    MINI LAP TECHNOLOGIES INC.
    Date Cleared
    2007-04-05

    (58 days)

    Product Code
    OCW
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    MINI LAP TECHNOLOGIES INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MINI LAP Pediatric Instruments with MEDUSA Clamping system are a family of minimally invasive devices with the means to penetrate soft tissue to access certain areas of the human anatomy. The devices are used to grasp, hold, and manipulate other soft internal tissues as well as items such as hernia mesh, during pediatric surgery.
    Device Description
    The MNI LAP Pediatric Instruments with MEDUSA Clamping system are a family of minimally invasive devices intended for pediatric surgery. The devices penetrate soft tissue to access certain areas of the human anatomy. The devices are used to grasp, hold, and manipulate other soft internal tissues as well as items such as hernia mesh, during pediatric surgery. Prior to insertion, the physician must depress the safety button and retract the instrument into the needle. The needle is inserted through the soft tissue under visualization. Once the needle has penetrated the soft tissue, the physician will advance the instrument into the body cavity using the handle. As the instrument advances, the jaws of the instrument will open. The instrument will be offered in various configurations including babook clamp, bowel clamp, and hernia clamp. The device includes a selfsching safety that prohibits the jaws from returning to their fully retracted position while in use, which acts as a blunt shield for the sharp needle tip. The device is provided in the following configurations: | Length | Clamp Type | |--------|---------------| | 150mm | Bowel Clamp | | 150mm | Babcock Clamp | | 150mm | Hernia Clamp | The devices are sterile disposable, single patient only. The devices were designed to hold pneumoperitoneum during use ..
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    K Number
    K070686
    Device Name
    MINI LAP INSTRUMENTS
    Manufacturer
    MINI LAP TECHNOLOGIES INC.
    Date Cleared
    2007-04-05

    (24 days)

    Product Code
    OCW
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    MINI LAP TECHNOLOGIES INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MINI LAP Instruments are a family of minimally invasive devices with the means to penetrate soft tissue to access certain areas of the human anatomy. The devices are used to grasp, hold, and manipulate other soft internal tissues as well as items such as hernia mesh.
    Device Description
    The MINI LAP Instruments are a family of minimally invasive devices. The devices penetrate soft tissue to access certain areas of the human anatomy. The devices are used to grasp, hold, and manipulate other soft internal tissues as well as items such as hernia mesh. Prior to insertion, the physician must depress the safety button and retract the instrument into the needle. The needle is inserted through the soft tissue under visualization. Once the needle has penetrated the soft tissue, the physician will advance the instrument into the body cavity using the handle. As the instrument advances, the jaws of the instrument will open. The instrument will be offered in various configurations including babcock clamp, bowel clamp, and hernia clamp. The device includes a selfactivating safety that prohibits the iaws from returning to their fully retracted position while in use. which acts as a blunt shield for the sharp needle tip. The devices are sterile disposable, single patient only. The devices were designed to hold pneumoperitoneum during use.
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