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The Laparoscopic FMsealer is an electrosurgical instrument intended for use in open and laparoscopic surgical procedures, including general and gynecologic procedures where ligation and division of vessels, including lymph vessels, is desired. It can be used to ligate and divide vessels up to and including 7 mm and bundles as large as will fit in the jaws of the instrument. The Laparoscopic FMsealer has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these purposes.

Electrosurgical cutting and coagulation devices (and accessories) are devices intended to remove tissue and control bleeding by use of high-frequency electrical current (see 21 CFR §878.4400). They are classified as Class II (510(k)) devices. The Laparoscopic FMsealer is a sterile, single-patient use, hand-held surgical instrument intended for ligation and division of vessels. The Laparoscopic FMsealer must be connected to a generator (Domain Surgical's FMwand Generator) by an accessory cable (Domain Surgical's FMwand Power Module). It is capable of blunt dissection, grasping and division of tissue enclosed within its jaws during open or laparoscopic procedures. The outer diameter of the instrument shaft is 5mm, with a working length of 36cm. The Laparoscopic FMsealer includes a rotation knob, front lever and two actuation buttons. The rotation knob, located at the distal end of the handle, allows for a full 360 degrees of rotation of the jaws to improve visibility of the tissue as well as permit access to tissues on differing planes. The front lever closes the jaws of the device which allows pressure to be applied to the tissue between the jaws. The actuation buttons activate the transfer of current from the generator to the tip of the device which creates the heat necessary for sealing and dividing. This system creates sealing, cutting and coagulation of heat and compression (from the opposing jaws of the device) to tissue bundles and vessels interposed between the jaws of the instrument. The Laparoscopic FMsealer has been shown to cut and seal vessels (veins and arteries) up to and including 7mm in diameter.

The Open FMsealer is intended for use in general and gynecological surgery and other open surgical procedures where ligation of vessels, including lymph vessels, is desired. The system creates a vessel ligation (seal) by the application of heat (coagulation) to vessels interposed between the jaws of the device. The Open FMsealer can be used to seal and ligate vessels up to 7mm and tissue bundles as large as will fit in the jaws of the instrument. The Open FMsealer has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these purposes.

An electrosurgical cutting and coagulation device (and accessories) is a device intended to remove tissue and control bleeding by use of high-frequency electrical current (see 21 CFR §878.4400). It is classified as a Class II (510(k)) device. The Open FMsealer is a device intended for sealing of vessels and for soft tissue cutting and coagulation. The device is designed to be used only with the FMwand Generator (K130606). The two-piece device consists of a sterile, single-use patient-contacting shears section (Open FMsealer) and an accessory cable (Power Module or PM) that connects the FMsealer to the generator. The dual footpedal connects to the rear of the generator and can be used to activate the FMsealer if desired by the user. The Open FMsealer is a hand-held surgical instrument intended for use in open surgical procedures where ligation of vessels or cutting and coagulation of soft tissue is desired. The Open FMsealer consists of a scissor-like handle with two actuation buttons and jaws to grasp the tissue to be affected. The Open FMsealer is connected to the FMwand Generator (K130606) by the Power Module. The connectors on both ends of the Power Module are designed to fit only the FMwand Generator and FMwand sterile, disposable accessories. The power module and FMwand Generator were previously cleared as part of K130606. This system creates sealing, cutting and coagulation by the application of heat and compression to tissue bundles and vessels interposed between the iaws of the instrument. Like the predicate device, the Open FMsealer includes actuation buttons that can be used to activate the device. The Open FMsealer has been shown (in animal studies) to cut and seal vessels up to and including 7mm in diameter, lymphatics and tissue bundles as large as will fit into the jaws of the device.

The FMwand Handpiece SE is indicated for cutting and coagulation of soft tissue during surgical procedures, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.

The FMwand Handpiece SE is a sterile, single-patient use, soft tissue cutting and coagulation device intended to be used with the FMwand Generator and FMwand Power Module (both previously cleared in 510(k) #K130606) and also with an effective user-supplied smoke evacuation system.

The FMwand Ferromagnetic Surgical System is indicated for cutting and coagulation of soft tissue during surgical procedures, including Gynecologic procedures (open, transabdominal only).

The FMwand Ferromagnetic Surgical System is a soft tissue cutting and coagulation device that consists of the FMwand Generator that is electrically connected to the sterile, single-use FMwand Handpiece by the FMwand Power Module (a resterilizable, reusable accessory cable) and a single-use, sterile air line. Like the predicate device, the handpiece includes actuation buttons that can be used to activate the handpiece tip. Also like the predicate device, an optional footpedal can be used to activate the handpiece. The connectors at both ends of the FMwand Power Module are designed to fit only the FMwand Generator and FMwand sterile, disposable accessories. The FMwand Power Module is provided non-sterile. It is intended to be cleaned and sterilized prior to the initial use and before each subsequent reuse.

The Domain Surgical System is indicated for cutting and coagulation of soft tissue during surgical procedures, including Gynecologic procedures (open transabdominal only).

An electrosurgical cutting and coagulation device (and accessories) is a device intended to remove tissue and control bleeding by use of high-frequency electrical current (21 CFR §878.4400). It is classified as a Class II (510(k)) device. The Domain Surgical System is a soft tissue cutting and coagulation device that consists of a generator that is electrically connected to a sterile, single-use handpiece and an optional footswitch. Like the predicate devices, the handpiece includes an actuation button that can be used to activate heating in the handpiece tip. Also like the predicate devices, an optional footswitch can be used to activate the system.

The Domain Surgical System is indicated for cutting and coagulation of soft tissue.

An electrosurgical cutting and coagulation device (and accessories) is a device intended to remove tissue and control bleeding by use of high-frequency electrical current (21 CFR §878.4400). It is classified as a Class II (510(k)) device. The Domain Surgical System is a soft tissue cutting and coagulation device that consists of a generator that is electrically connected to a sterile, single-use handpiece and an optional footswitch. Like the predicate devices, the handpiece includes an actuation button that can be used to activate heating in the handpiece tip. Also like the predicate devices, an optional footswitch can be used to activate the handpiece.