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ClearHemograsper has been designed to be used with endoscopes to cauterize and coagulate or to perform hemostasis using high-frequency current within the digestive tract.

ClearHemograsper is a monopolar endoscopic instrument intended to coagulate or to perform hemostasis using high-frequency current within the digestive tract. It can assist in endoscopic surgical procedures such as ESD (Endoscopic Submucosal Dissection). ClearHemograsper consists a Slider for opening or closing the Jaw, a Catheter Tube which is a part passing through the working channel of endoscope, a pair of Jaw for catching the bleeding site and for delivering high-frequency current, a plug for connecting with high frequency transmission equipment, and an irrigation port for removing foreign substances by injecting distilled water or saline solution. It is available in various working lengths.

This instrument has been designed to be used with endoscopes to collect tissue, cauterize, coagulate and perform hemostasis using high-frequency current within the digestive tract.

The subject device Disposable Hot Biopsy Forceps is a sterile, single-use endoscopic device, intended to be used with endoscopes to cut, coagulate and stop bleeding in the digestive tract by using high-frequency current. The disposable Hot Biopsy Forceps consists of an insertion part and a handle part. The insertion part includes a jaw assembly and a spring tube; the handle part includes a handle, a finger ring, a conductive column, a rotating sleeve, a locking sleeve, and a sheath tube. The subject device has 7 specifications. The differences among these models are the jaws type, Jaw O.D, and Working Length. The subject device is EO sterilized to achieve the Sterility Assurance Level (SAL) of 10 ° and placed in a sterility maintenance package to ensure a shelf life of 3 years. The materials used for construction of Disposable Hot Biopsy Forceps are typical for this type of medical device. Materials of Jaw and spring tube is stainless steel SUS304, the Sheath tube is made of HDPE, the Locking sleeve, Rotating sleeve and handle are made of ABS. The conductive column is made of H62.

These products are used in combination with an applicable endoscope to perform the endoscopic treatments for the target site in the gastrointestinal tract, such as ablation, incision, cauterization, coagulation and avulsion of tissue and arrest of bleeding, and to inject saline or submucosal injection agent for endoscopic surgery into the submucosal layer in the gastrointestinal tract, which is exposed after dissection, under the management of physicians in medical facilities. Never use this product for any other purpose.

FUJIFILM Diathermic Slitter (FlushKnife) is an electrosurgical instrument that removes tissue and controls bleeding by use of high-frequency ("HF") electrical current. The device is available with either a needle or ball tip slitter and comes in a variety of sizes.

Bipolar Coagulation Forceps have been designed to be used with endoscopes to cauterize and coagulate or to perform hemostasis using high-frequency current within the digestive tract.

The Bipolar Coagulation Forceps described in this submission are a sterile, single use devices compatible with the working channel of endoscope. The device is used with endoscopes to cauterize and coagulate or to perform hemostasis using high-frequency current within the digestive tract. Bipolar Coagulation Forceps consists of Handle part, plug, sheath and forceps part.

These instruments have been designed to be used with endoscopes to cauterize and coagulate or to perform hemostasis using high-frequency current within the digestive tract.

The proposed Ensure™ Single-Use Coagulation Forceps is a sterile, single-use endoscopic device, intended to be used with endoscopes to cauterize and coagulate or to perform hemostasis using high-frequency current within the digestive tract. The proposed device is only for adult patients. The Coagulation Forceps is a hemostasis device which combines both mechanical property and energy. It consists of a jaw, coated spring sheath, high frequency electrical interface and handle. The Coagulation Forceps can be advanced through an appropriate endoscope channel to reach targets and by pushing and pulling its Finger Ring of the handle, the forceps opens and closes. The bleeding point will be clamped with the Coagulation Forceps. At that point, high-frequency and high-voltage power will be delivered at the precise site of bleeding using an electrosurgical current generator so as to achieve hemostasis. The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 106 and placed in a sterility maintenance package to ensure a shelf life of 2 years.

Disposable biopsy forceps are used to obtain mucosal tissue samples for pathology using monopolar energy, including the avulsion technique, during endoscopic procedures in the gastrointestinal tract, for example the esophagus, stomach, small intestine and colon. Tissue samples will be submitted for pathologic review. This product is intended only for adult populations.

The Avulsion Forceps is used during endoscopic procedures in the gastrointestinal tract. The avulsion technique in Endoscopy involves using both mechanical forces as well as high energy cutting current to tear the tissue away from the gastrointestinal tract. The Avulsion Forceps consists of a handle on the proximal end that actuates two toothed jaws on the distal end. An Olympus-style active cord connector is included that allows the Avulsion Forceps to be connected to an electrosurgical generator for use with monopolar energy. The device also includes a spring sheath catheter housing the drive cable which transfers the linear motion of the handle slider to open and close the jaws.

This device is used for endoscopic histological sampling or electrocoagulation of various tissues, within the gastrointestinal and bronchial tracts, via the operating channel of endoscopic instruments.

The proposed device Disposable Hot Biopsy Forceps is a sterile, single-use endoscopic device, intended to be used for endoscopic histological sampling or electrocoagulation of various tissues, within the gastrointestinal and bronchial tracts, via the operating channel of endoscopic instruments. It consists of a flexible wire cable and jaws which can be opened and closed by a handle. When passed through an endoscope the forceps can be activated to deliver a monopolar electrical current for histological sampling or electrocoagulation with the jaws. The main component of the proposed device is jaws, spring sheath and handle. The proposed device has four (4) models, HBF55-11023180 and HBF55-11023230, HBF65-11023180 and HBF65-11023230. HBF65-11023180 and HBF65-11023230 are two new models added. The differences between the two new models and the two approved models (predicate device) are the color of Handle and the jaws. The news models are White-blue Handle and Alligator Forceps; the two approved models are Grey-blue Handle and oval forceps. The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10 to the power of -6 and placed in a sterility maintenance package to ensure a shelf life of 3 years.

Ensizor® Monopolar Endoscopic Scissors are designed to cut and dissect tissue, cut sutures and cut nonmetallic materials during all flexible endoscopic procedures. Ensizor® Monopolar Endoscopic Scissors are designed to cut and dissect tissue, cauterize tissue, cut sutures and cut non-metallic materials during all flexible endoscopic procedures.

The Ensizor Monopolar Endoscopic Scissors is a single-use ethylene oxide sterile electrosurgical scissors. This device is designed to be used with an electrosurgical monopolar HF generator to cut and dissect tissue, cauterize tissue, cut sutures and cut non-metallic materials during all flexible endoscopic procedures. The device is compatible with flexible endoscopes with a minimum channel diameter of 2.8 mm. The maximum insertion portion diameter is 2.6 mm, and insertion lengths are 165 cm and 235 cm. The patented Edge Flex™ technology used for the Scissor Blades ("Blades") enhances the cutting performance of this flexible endoscopic scissors. The Ensizor's rotation feature enables accurate-radial positioning, and the nitinol actuator wire allows for tortuous endoscopic paths while minimizing loss of distal control. The Blades are designed with blunt tips to enable the atraumatic dissection of tissue planes and when closed, make a non-sharp rounded cauterizing surface.

The Captura® Disposable Hot Biopsy Forceps is used endoscopically in conjunction with monopolar electrosurgical current to obtain gastrointestinal mucosal tissue biopsies and for removal of sessile polyps. This device is indicated for adult use only.

The Captura® Disposable Hot Biopsy Forceps is a sterile, single use device compatible with the accessory channel of endoscopes. The device consists of stainless steel forceps cups joined to a spool handle by a Pebax-coated stainless steel coilspring catheter and stainless steel drive cable. The handle's spool actuates the opening and closing of the forceps cups and its brass electrosurgical pin is intended for connection to an electrosurgical generator.

This instrument has been designed to be used with an Olympus endoscope to electrosurgically collect tissue, to electrosurgically cauterize or to perform electrosurgical hemostasis within the urinary organs.

The Single Use Hot Biopsy Forceps FD-231 consists of a handle and insertion portion. Fenestrated cups in the distal end of insertion are activated in the open and closed position by maneuvering the slider in the handle. During operation, insertion will be inserted into endoscopes. Once the tissue is held by the cups, the tissue is subjected to high frequency electric current transmitted from plug which allows for collecting tissue. Once the tissue is touched by closed cups, the tissue is subjected to high frequency electric current transmitted from plug which allows for cauterization and hemostasis. By means of high frequency electric current passing through the tissues between electrical plate attached on patient`s skin and the cups, heat will be produced from electricity resistance by the tissue and the heat will be utilized for collecting tissue, cauterization and hemostasis.