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510(k) Data Aggregation
K Number
K150519Device Name
ManipulatOR PRO, ManipulatOR
Manufacturer
GYNETECH PTY. LTD.
Date Cleared
2015-08-19
(170 days)
Product Code
LKF
Regulation Number
884.4530Why did this record match?
Applicant Name (Manufacturer) :
GYNETECH PTY. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ManipulatOR is indicated for manipulation of the uterus during laparoscopic procedures including laparoscopic assisted vaginal hysterectomy (LAVH), laparoscopic tubal occlusion, and diagnostic laparoscopy. The ManipulatOR, when used together with the McCartney Tube, is indicated for manipulation of the uterus during laparoscopic procedures requiring maintenance of pneumoperitoneum, such as total laparoscopic hysterectomy (TLH).
The ManipulatOR PRO is indicated for manipulation of the uterus during laparoscopic procedures such as laparoscopic assisted vaginal hysterectomy (LAVH), total laparoscopic hysterectomy (TLH), laparoscopic tubal occlusion and diagnostic laparoscopy. The ManipulatOR PRO maintains pneumoperitoneum by sealing the vagina once colpotomy is performed.
Device Description
The ManipulatOR and ManipulatOR PRO are sterile, single-use uterine manipulators indicated for uterine manipulation and preventing loss of pneumoperitoneum during laparoscopic gynecology procedures. The ManipulatOR and ManipulatOR PRO are silicone insulated and anatomically designed stainless steel manipulators with a silicone intrauterine balloon at one end and an external handle at the other end. The balloon is inflated with air using a 20cc syringe that is supplied with the device.
The ManipulatOR and ManipulatOR PRO are designed to improve physician visibility of the uterus and cervix during various medical examinations and procedures. Like many uterine elevators currently in the market place, the ManipulatOR and ManipulatOR PRO are designed for use in surgical procedures requiring cervical uterine motions with elevation and retraction of the vaginal fornices. The ManipulatOR and ManipulatOR PRO can help to create the tension on the tissue to assist in ligament dissection. In the most commonly used procedure, the total laparoscopic hysterectomy, the uterine elevator must expose the fornix and seal the vagina following removal of the uterus.
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K Number
K142700Device Name
InsufflatOR Needle
Manufacturer
GYNETECH PTY. LTD.
Date Cleared
2014-12-19
(88 days)
Product Code
HIF
Regulation Number
884.1730Why did this record match?
Applicant Name (Manufacturer) :
GYNETECH PTY. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The InsufflatOR Needle™ is intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide, to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.
Device Description
The Gynetech InsufflatOR Needle is a sterile disposable Veress needle which is available in 120mm or 150mm length. The device is equipped with a spring-loaded, round-tipped obturator. In addition, there is a "slide switch" which permits easy ON-OFF control of gas flow. The most proximal end contains a male luer lock connector for connection to a CO2 gas line. The InsufflatOR Needle has applications in gynaecological laparoscopy and other laparoscopic procedures.
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K Number
K142164Device Name
MANIPULATOR; MANIPULATOR PRO
Manufacturer
GYNETECH PTY. LTD.
Date Cleared
2014-12-17
(133 days)
Product Code
LKF
Regulation Number
884.4530Why did this record match?
Applicant Name (Manufacturer) :
GYNETECH PTY. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ManipulatOR is indicated for manipulation of the uterus during laparoscopic procedures including laparoscopic assisted vaginal hysterectomy (LAVH), laparoscopic tubal occlusion, and diagnostic laparoscopy. The ManipulatOR, when used together with the McCartney Tube, is indicated for manipulation of the uterus during laparoscopic procedures requiring maintenance of pneumoperitoneum, such as total laparoscopic hysterectomy (TLH).
The ManipulatOR PRO is indicated for manipulation of the uterus during laparoscopic procedures such as laparoscopic assisted vaginal hysterectomy (LAVH), total laparoscopic hysterectomy (TLH), laparoscopic tubal occlusion and diagnostic laparoscopy. The ManipulatOR PRO maintains pneumoperitoneum by sealing the vagina once colpotomy is performed.
Device Description
The ManipulatOR and ManipulatOR PRO are sterile, single-use uterine manipulators indicated for uterine manipulation and preventing loss of pneumoperitoneum during laparoscopic gynecology procedures. The ManipulatOR and ManipulatOR PRO are silicone insulated and anatomically designed stainless steel manipulators with a silicone intrauterine balloon at one end and an external handle at the other end. The balloon is inflated with air using a 20cc syringe that is supplied with the device. The ManipulatOR and ManipulatOR PRO are designed to improve physician visibility of the uterus and cervix during various medical examinations and procedures. Like many uterine elevators currently in the market place, the ManipulatOR and ManipulatOR PRO are designed for use in surgical procedures requiring cervical uterine motions with elevation and retraction of the vaginal fornices. The ManipulatOR and ManipulatOR PRO can help to create the tension on the tissue to assist in ligament dissection. In the most commonly used procedure, the total laparoscopic hysterectomy, the uterine elevator must expose the fornix and seal the vagina following removal of the uterus.
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K Number
K051594Device Name
MCCARTNEY ACCESS TUBE
Manufacturer
GYNETECH PTY. LTD.
Date Cleared
2005-09-02
(78 days)
Product Code
HEW
Regulation Number
884.1640Why did this record match?
Applicant Name (Manufacturer) :
GYNETECH PTY. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The McCartney Access Tube is intended to be inserted transvaginally to establish a path of entry for minimally invasive instruments and as a template for dissection, while maintaining pneumoperitoneum during laparoscopic hysterectomy. The instrument is indicated for use in laparoscopically assisted vaginal hysterectomies. The instrument is also a conduit for the extraction of specimens.
Device Description
The McCartney Access Tube is a sterile, single use instrument consisting of a silicone rubber tube, a polypropylene body and a silicone rubber cap. The McCartney Access Tube is available in 35mm and 45mm diameters. The instrument is packaged with a stopcock that can be inserted on the cap in order to insufflate and desufflate the peritoneum along with minizing gas leakage. The cap has two valves for 5mm and 10mm minimally invasive instrument access. The distal end of the silicone rubber tube is beveled and has a textured surface for internal identification.
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