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510(k) Data Aggregation

    K Number
    K141523
    Device Name
    ALLY UPS
    Manufacturer
    COOPER SURGICAL, INC.
    Date Cleared
    2014-11-25

    (169 days)

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

    COOPER SURGICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ally Uterine Positioning System™ (Ally UPS) is intended to assist the surgical staff in mounting, positioning, and holding uterine manipulators during gynecological laparoscopic procedures. It is intended for use by trained operating room personnel in an operating room environment. The Adapter Drape for the Ally Uterine Positioning System™ (Ally UPS) is intended to assist the surgical staff in mounting, positioning, and holding uterine manipulators during gynecological laparoscopic procedures. It is intended for use by trained operating room personnel in an operating room environment.
    Device Description
    The Cooper Surgical ALLY Uterine Positioning System™ (UPS) consists of a single multisegmented, articulated Arm that attaches to a standard OR bed rail and a separate, sterile distal adapter to accommodate a uterine manipulator. When unlocked, the articulation of the Arm allows the attached manipulator to be positioned by the user. The Arm is then locked in the desired position by depressing a foot pedal, activating a linear actuator which applies tension to an internal cable, drawing the segments together and locking the Arm. The segmented design of the Arm allows lateral/medial movement from a single point, allowing the System to be attached to one side of the OR table. The ALLY Uterine Positioning System™ (UPS) is not intended for patient contact. The Adapter Drape for the ALL Y Uterine Positioning System™ (UPS) is provided sterile (sterilized by ethylene oxide). The ALLY UPS Adapter Drape secures either the Cooper Surgical RUMI II Uterine Manipulator Handle or the Advincula Arch Uterine Manipulator Handle to the distal end of the ALLY Arm. After attaching the Adapter, the sterile Drape is deployed to cover the non-sterile ALLY UPS Arm, maintaining the sterile field and protecting the Arm from contamination during the procedure.
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    K Number
    K140754
    Device Name
    COOPER SURGICAL LEISEGANG COLPOSCOPE SYSTEM
    Manufacturer
    COOPER SURGICAL, INC.
    Date Cleared
    2014-10-23

    (211 days)

    Product Code
    HEX
    Regulation Number
    884.1630
    Why did this record match?
    Applicant Name (Manufacturer) :

    COOPER SURGICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cooper Surgical Leisegang Colposcope Systems are intended for the magnified viewing of the tissues of the vagina, cervix, and external genitalia in order to assist doctors in diagnosing abnormalities such as lesions or cancer, and selecting areas for biopsy. The images from Cooper Surgical Leisegang Colposcope Systems may be viewed directly and/or on a color monitor (if so equipped). The Cooper Surgical Leisegang Colposcope Systems are intended for use in hospitals, clinics, and doctor's offices.
    Device Description
    The Cooper Surgical Leisegang Colposcope(s) and accessories are optical colposcopes designed for non-contact visualization of the tissues of the cervix, vulva, vagina, and anogenital areas. Depending on the model and/or mode selected, they provide direct visual, photographic, and/or high resolution color imaging of the selected area.
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