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510(k) Data Aggregation
K Number
K223718Device Name
HandX Self-Righting Needle Holder
Manufacturer
Human Xtensions Ltd.
Date Cleared
2023-06-05
(175 days)
Product Code
GCJ
Regulation Number
876.1500Why 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
K230491Device Name
HandX Monopolar Scissors
Manufacturer
Human Xtensions Ltd.
Date Cleared
2023-05-10
(76 days)
Product Code
GCJ, GEI
Regulation Number
876.1500Why 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
K222011Device Name
HandX Instrument - Monopolar Spatula
Manufacturer
Human Xtensions Ltd.
Date Cleared
2023-01-12
(189 days)
Product Code
GCJ, GEI
Regulation Number
876.1500Why 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
K212214Device Name
HandX
Manufacturer
Human Xtensions Ltd.
Date Cleared
2021-09-13
(60 days)
Product Code
GCJ, GEI, NAY
Regulation Number
876.1500Why 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
K203603Device Name
Monopolar Hook
Manufacturer
Human Xtensions Ltd.
Date Cleared
2021-02-01
(54 days)
Product Code
GCJ, GEI
Regulation Number
876.1500Why 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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