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510(k) Data Aggregation

    K Number
    K223718
    Device Name
    HandX™ Self-Righting Needle Holder
    Manufacturer
    Human Xtensions Ltd.
    Date Cleared
    2023-06-05

    (175 days)

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

    Human Xtensions Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HandX is intended to assist in the control of Human Xtensions laparoscopic instruments including needle holder and grasper, for endoscopic manipulation of tissue, including grasping, approximation, ligation, suturing, during laparoscopic surgical procedures. It is intended to be used by trained physicians in an operating room environment in accordance with its Instructions for Use.
    Device Description
    The Self-Righting Needle Holder is a single-use, disposable, ETO sterilized instrument for use with the HandX™ device. The Self-Righting Needle Holder is connected to the HandX™ and transmits the motors' rotations to articulate the movement of the Self-Righting Needle Holder's end effector. Self-Righting Needle Holder orients the suturing needle vertically to 90° mounting. It is designed to address the surgeons' needs relating to suturing for various surgical purposes.
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    K Number
    K230491
    Device Name
    HandX™ Monopolar Scissors
    Manufacturer
    Human Xtensions Ltd.
    Date Cleared
    2023-05-10

    (76 days)

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

    Human Xtensions Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HandX™ is intended to assist in the control of Human Xtensions laparoscopic instruments including needle holder, grasper and monopolar instruments, for endoscopic manipulation of tissue, including grasping, approximation, ligation, suturing, cutting and/or coagulation, during laparoscopic surgical procedures. The HandX™ monopolar instruments are connected by a standard cable to a standard electrosurgical power source. It is intended to be used by trained physicians in an operating room environment in accordance with its Instructions for Use
    Device Description
    The Monopolar Scissors is a single-use, disposable, ETO sterilized instrument for use with the HandX™ device. The Monopolar Scissors is connected to the HandX and transmits the motors' rotations to articulate the movement of the Monopolar Scissors' end effector. It is designed to address surgeons' needs relating to the application of monopolar diathermy for various surgical purposes.
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    K Number
    K222011
    Device Name
    HandX Instrument - Monopolar Spatula
    Manufacturer
    Human Xtensions Ltd.
    Date Cleared
    2023-01-12

    (189 days)

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

    Human Xtensions Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HandX is intended to assist in the control of Human Xtensions laparoscopic instruments including needle holder, grasper and monopolar instruments, for endoscopic manipulation of tissue, including grasping, approximation, ligation, suturing, cutting and/or coagulation, during laparoscopic surgical procedures. The HandX monopolar instruments are connected by a standard cable to a standard electrosurgical power source. It is intended to be used by trained physicians in an operating room environment in accordance with its Instructions for Use.
    Device Description
    The HandX™ Monopolar Spatula is a single-use sterile electrosurqical electrode for use with the HandX™ device. The Monopolar Spatula is connected to the HandX™ device and transmits the device motors' rotation to articulate the movement of the end effector of the Monopolar Spatula. It is designed to address surgeons' needs relating to the application of monopolar diathermy for various surgical purposes. The Monopolar Spatula is connected to a standard electrosurgical unit via a standard generator cable.
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    K Number
    K212214
    Device Name
    HandX
    Manufacturer
    Human Xtensions Ltd.
    Date Cleared
    2021-09-13

    (60 days)

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

    Human Xtensions Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HandX is intended to assist in the control of Human Xtensions laparoscopic instruments including needle holder, grasper and monopolar instruments, for endoscopic manipulation of tissue, including grasping, approximation, ligation, suturing, cutting and/or coagulation, during laparoscopic surgical procedures. The HandX monopolar instruments are connected by a standard cable to a standard electrosurgical power source. It is intended to be used by trained physicians in an operating room environment in accordance with its Instructions for Use.
    Device Description
    The Human Xtensions HandX is a handheld powered laparoscopic device. The HandX enables, by its attached instruments Grasper, Needle Holder and Monopolar Hook, the surgeon to perform a variety of minimally invasive surgeries. As the device is controlled by the surgeon's hand, it acts as a "surgeon's hand extension," enhancing maneuverability and control. The HandX device is electromechanically controlled and includes both hardware and software. The device is comprised of two main parts: the Handpiece and the Instrument. The Handpiece consists of a reusable Control Interface (CI) handle and Handpiece Body that translates the surgeon's maneuvers and movements of their hands by means of control buttons to the instrument-articulating tip. The tip moves according to the CI's direction. Prior to use, a set of Power Cable, Finger Pads, Arc and Spacer are assembled on the Handpiece and the Handpiece is covered with a standard sterile cover (not provided with the HandX device). After use, the Instrument is disposed of, and the Handpiece is cleaned and disinfected per specifications in the Instructions for Use.
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    K Number
    K203603
    Device Name
    Monopolar Hook
    Manufacturer
    Human Xtensions Ltd.
    Date Cleared
    2021-02-01

    (54 days)

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

    Human Xtensions Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HandX is intended to assist in the control of Human Xtensions laparoscopic instruments including needle holder, grasper and monopolar instruments, for endoscopic manipulation of tissue, including grasping, approximation, ligation, suturing, cutting and/or coagulation, during laparoscopic surgical procedures. The HandX monopolar instruments are connected by a standard electrosurgical power source. It is intended to be used by trained physicians in an operating room environment in accordance with its Instructions for Use.
    Device Description
    The Monopolar Hook is a single use sterile electrosurgical electrode for use with the HandX™ device. The Monopolar Hook is connected to the HandX device and transmits the HandX device motors' rotation in order to articulate the movement of the end effector of the Monopolar Hook. It is designed to address surgeons' needs relating to the application of monopolar diathermy for various surgical purposes. The Monopolar Hook is connected to a standard electrosurgical unit via a standard generator cable.
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