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510(k) Data Aggregation

    K Number
    K130758
    Device Name
    KRONNER SIDE-KICK UTERINE MANIPULATOR HOLDER
    Manufacturer
    KRONNER PROTOTYPES, INC.
    Date Cleared
    2013-12-11

    (266 days)

    Product Code
    LKF
    Regulation Number
    884.4530
    Why did this record match?
    Applicant Name (Manufacturer) :

    KRONNER PROTOTYPES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Kronner Side-Kick is intended to assist the surgical staff in mounting, positioning and holding a uterine manipulator during gynecological laparoscopic surgical procedures. It is intended for use by trained operating room personnel in an operating room environment. For holding uterine manipulators during laparoscopic or open surgery on female pelvic organs.
    Device Description
    The Kronner Side-Kick uterine manipulator holder is used to mount, position and hold in position uterine or vaginal manipulators used in laparoscopic surgical procedures. It is made mostly from aluminum and stainless steel and is mounted to standard operating room tables and locked in position allowing surgical devices to be securely held in position for long periods of time. Use of the Sidek-Kick frees operating room staff for other activities and reduces fatigue associated with manually maintaining a device in position during surgical procedures. The manipulator is inserted into the patient using standard technique, then the Side-Kick is joined to the manipulator. With proper adapters the Side-Kick may be used with various manipulators, such as the RUMI, the V-Care and the Arch Koh, A gas supply module, which can be attached to the operating table rail, transfers nitrogen or compressed air from the wall or a portable tank to the Side-Kick holder through two flexible lines. When the switch is turned on the Side-Kick joints are locked. When the switch is turned off the Side-Kick joints are unlocked. Pressing a foot pedal releases all the Side-Kick joints for position changes. When the foot pedal is released the joints lock. The foot pedal is connected to the gas supply module through two lines covered by a protective hose. A branched gas line connects the two luers of the Arm assembly to the gas supply module. A single gas line connects the gas supply module to the main pivot. The Kronner Side-Kick remains external to the patient's body at all times.
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    K Number
    K000663
    Device Name
    KRONNER LOW PROFILE SCOPE HOLDER
    Manufacturer
    KRONNER PROTOTYPES, INC.
    Date Cleared
    2000-05-02

    (64 days)

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

    KRONNER PROTOTYPES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    KSH-4 Kronner Low Profile Scope Holder: For abdominal and thoracic endoscopic surgical procedures HPL2-CRL High pressure* Gas Line Set: For abdominal and thoracic endoscopic and arthroscopic surgical procedures KSHSA-3 Standard Arm Assembly: For abdominal and thoracic endoscopic surgical procedures C-1 Control: For abdominal, thoracic, arthroscopic, endoscopic surgery and holding manual surgical instruments ECB-2 Electronic Control Box: For abdominal, thoracic, arthroscopic, nasal endoscopic surgical procedures and holding manual surgical instruments GLW-1 Gas line wrench: For abdominal, thoracic, arthroscopic, nasal endoscopic surgical procedures and holding manual surgical instruments SEAH-1 Small Endoscope Accessory with Handle: For nasal endoscopic surgical procedures HPL1-BL1-CRL High pressure* Branched Gas Line Set: For nasal endoscopic surgical procedures and holding manual surgical instruments * Tolerates pressures to 150 PSI, do not use with pressures over 150 psi.
    Device Description
    The Kronner Low Profile Scope Holder with Electronic Control and Control Box is the same as the Kronner Low Profile Scope Holder (K973543) with mechanical control except that it has an electronic control, momentary button, and electronic control box with solenoids to control gas output.
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    K Number
    K973543
    Device Name
    KRONNER LOW PROFILE SCOPE HOLDER
    Manufacturer
    KRONNER PROTOTYPES, INC.
    Date Cleared
    1998-01-12

    (116 days)

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

    KRONNER PROTOTYPES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For abdominal, thoracic, arthroscopic and nasal endoscopic surgical procedures.
    Device Description
    The Kronner Low Profile Scope Holder consists of mechanical linkages that connect between the operating table side rail and the shaft or head of a rigid endoscope. A telescoping arm distinguishes the device from other endoscope holders. Inert nitrogen gas at 100-150 psi is used to provide the energy to multiple joints to lock the holder in position when a control button is released by the operator.
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