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The Voyant Open Fusion Device is a bipolar, electrosurgical device indicated for use with the Voyant electrosurgical generator in open procedures where the ligation and division of vessels and tissue bundles is desired. The device can seal and divide vessels up to and including 7mm in diameter and tissue bundles that can be captured in the jaws of the device. The device has not been shown to be effective for tubal coagulation for sterilization for sterilization procedures, and should not be used for these procedures. The Voyant 5mm Fusion device is a bipolar, electrosurgical device indicated for use with the Voyant electrosurgical generator in open and laparoscopic procedures where the ligation and division of vessels and tissue bundles is desired. The device can seal and divide vessels up to and including 7mm in diameter and tissue bundles that can be captured in the jaws of the device. The device has not been shown to be effective for tubal coagulation for sterilization for sterilization procedures, and should not be used for these procedures.

The Voyant Open Fusion and Voyant 5mm Fusion devices are advanced bipolar instruments that use RF energy, provided by the Voyant Electrosurgical Generator (K182244), to seal vessels up to and including 7mm in diameter. The devices may also be used to seal tissue bundles that can be captured in the devices' jaws. Each device features a mechanical, user-actuated blade for the division of sealed tissue.

The Voyant Maryland Fusion device is a bipolar, electrosurgical device indicated for use with the Voyant electrosurgical generator in open and laparoscopic procedures where the ligation of vessels and tissue bundles is desired. The device can seal and divide vessels up to and including 7mm in diameter and tissue bundles that can be captured in the jaws of the device. The device has not been shown to be effective for tubal coagulation for sterilization procedures, and should not be used for these procedures.

The Voyant Maryland Fusion device is an advanced bipolar instrument that uses RF energy, provided by the Voyant Electrosurgical Generator (K182244), to seal vessels up to and including 7mm in diameter. The device may also be used to seal tissue bundles that can be captured in the device jaws. The device features a mechanical, user-actuated blade for the division of sealed tissue.

The Voyant [5mm/Maryland] Fusion device is a bipolar, electrosurgical device indicated for use with the Voyant electrosurgical generator in open and laparoscopic procedures where the ligation of vessels and tissue bundles is desired. The device can seal and divide vessels up to and including 7mm in diameter and tissue bundles that can be captured in the jaws of the device. The device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.

The Voyant 5mm and Maryland Fusion devices are advanced bipolar instruments that uses RF energy, provided by the Voyant Electrosurgical Generator (K141288 & K182244), to seal vessels up to and including 7mm in diameter. The devices may also be used to seal tissue bundles that can be captured in the device jaws. The devices feature a mechanical, user-actuated blade for the division of sealed tissue.

The Transvaginal Access Platform is intended to be inserted transvaginally to establish a path of entry for minimally invasive instruments while maintaining insufflation during laparoscopic-assisted and vaginal gynecological procedures. The device is also a conduit for the extraction of specimens.

The Transvaginal Access Platform consists of an access channel component that is placed transvaginally to create a pathway to gynecological organs in the pelvic cavity. A GelSeal cap attaches to the access channel at the opening of the vagina. The cap allows for insufflation and smoke evacuation. Sleeves inserted through the cap allow for passage of 5mm to 12mm laparoscopic instrumentation. Visualization is achieved via introduction of an endoscope through a sleeve. The device is provided sterile.

The Voyant Maryland Fusion device is a bipolar, electrosurgical device indicated for use with the Voyant Electrosurgical Generator in laparoscopic procedures where the ligation of vessels and tissue bundles is desired. The device can seal and divide vessels up to and including 7mm in diameter and tissue bundles that can be captured in the jaws of the device. The device has not been shown to be effective for tubal coagulation for sterilization procedures, and should not be used for these procedures.

The Voyant Maryland Fusion device (Model Numbers: EB015, EB016, EB017, EB215, EB216, EB217) is an advanced bipolar instrument that uses RF energy, provided by the Voyant Electrosurgical Generator (K141288, K182244), to seal vessels up to and including 7mm in diameter. The device may also be used to seal tissue bundles that can be captured in the device jaws. The device features a mechanical, user-actuated blade for the division of sealed tissue.

The Voyant electrosurgical generator is indicated for use with Voyant devices in open and laparoscopic surgical procedures where the electrosurgical ligation of vessels or tissue bundles is desired.

The Applied Medical Voyant Electrosurgical Generator (ESG) is a tabletop radiofrequency (RF) power supply designed for use in electrosurgery. It operates outside the sterile field and is equipped with a receptacle for Voyant hand piece devices. The ESG enclosure is constructed of various metals and polymers and houses all electrical hardware and software components. The front panel features an LCD and buttons for the navigation, adjustment, and selection of ESG settings.

The Dissecting Balloon System is indicated for patients undergoing laparoscopic surgery requiring tissue separation of the extraperitoneal space.

Applied Medical's Dissecting Balloon System consists of a rigid cannula with an inflatable balloon attached at the distal end that achieves separation of tissue planes during laparoscopic surgery. The system is provided sterile. The system includes three main components: An introducer that facilitates insertion of the balloon through an abdominal incision. A dissecting cannula with attached balloon, which is compatible with a 10mm endoscope to allow for visualization during tissue separation. Two balloon configurations will be offered (oval and round). An inflation bulb that is used to manually inflate the balloon

The GelPOINT® Path Transanal Access Platform is indicated for multiple instrument or camera access through the anus to perform various diagnostic and/or therapeutic procedures by using additional instruments.

GelPOINT Path is inserted into the anal canal to establish access to the rectum and lower sigmoid colon in preparation for transanal endoscopic surgery. The access channel lumen may be closed off with an airtight cap. The cap allows for insufflation of the surgical site. The cap is constructed of a gel material through which multiple sleeves may be placed. These sleeves establish ports that allow passage of a laparoscope and laparoscopic instruments without loss of insufflation. GelPOINT Path was previously cleared in access channel lengths ranging from 4.5cm to 15cm. The proposed clearance for the access channel length is 3.5cm to 15cm.

The Epix® Electrosurgical Probes are indicated for irrigation, evacuation of fluids, and electrosurgical cutting and coagulation during general laparoscopic procedures.

Electrosurgical probes are reusable suction and irrigation devices designed for electrosurgical cutting and coagulation of tissue during general laparoscopic procedures.

The GelPOINT Path Transanal Access Platform is indicated for multiple instrument or camera access through the anus to perform various diagnostic and therapeutic procedures by using additional accessories.

The subject device is inserted into the rectum to establish an access port into the lower sigmoid colon in preparation for transanal endoscopic microsurgery. The port lumen measures 40mm in diameter and may be capped off with an airtight lid. The lid allows the colon to be insufflated, thus enlarging the operative space. The airtight lid is constructed of a gel material through which multiple trocars may be placed. These trocars establish multiple ports that allow passage of laparoscopes and laparoscopic instruments without loss of insufflation. The design has all the functionality of a simple, two-piece proctoscope but with significant additional versatility, capability and effectiveness.