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The BaroSense Endogastric Tube (EGT) is indicated for use with an endoscope where multiple endoscopic intubations are anticipated.

The EGT is a reusable overtube used in hospitals or surgery centers to provide a channel for the delivery and removal of endoscopic devices from the mouth to the stomach. It is intended for use when multiple endoscopic intubations, or endoscopic instrument/tool exchanges, are anticipated. A flexible Introducer Bougie has a tapered tip to assist in introduction of the EGT through the mouth and esophagus. The bougie has an internal lumen to accommodate a 5 mm endoscope. The EGT and Introducer Bougie are supplied non-sterile. The predicate device has identical technological characteristics. However, the predicate EGT is provided as a single-patient-use, disposable unit, with an internal bougie introducer included in the package. The modified device is provided as a reusable overtube and single-use bougie. The predicate device working tube is a PVC tube with an embedded stainless steel reinforcement coil, whereas the modified device is a Tecoflex tube with an embedded stainless steel reinforcement coil. The proximal handle of the modified device has an added feature to allow the endogastric tube to grip and seal to Introducer Bougie or other endoscopic devices. This gripping action prevents relative motion between the overtube and the other devices, e.g., the Introducer Bougie.

The BaroSense ACE Stapler is indicated for endoluminal trans-oral tissue approximation and ligation in the gastrointestinal tract.

The ACETM Stapler is a surgical stapler used in hospitals or surgery centers for staple closure on the wall of the stomach or gastrointestinal tract. The single-patient-use, disposable stapler head is supplied non-sterile and is fitted with a sterile, single-use staple cartridge. The stapler head is attached to a reusable, flexible stapler handle that controls the position and articulation of the stapler head. In use, the stapler is introduced into the patient through the mouth. A flexible endoscope passes through the stapler for gastric tissue visualization. The stapler works in conjunction with a vacuum pump to create a plication (tissue fold) in the GI tract, which is then compressed. The stapler then places a double ring of titanium staples (8 staples). A non-absorbable ring helps reinforce the staple placement in the tissue. The tissue compression and stapling functions are controlled by commercially available inflation syringes. An endogastric overtube may be used to protect the esophageal tissues during repeated insertions of the device. The overtube, flexible endoscope, vacuum pump and inflation syringes used with the stapler are all commercially available medical devices, not the subject of this 510(k), and are not supplied with the stapler.

The BaroSense ACE Stapler and Cartridge are indicated for endoluminal trans-oral tissue approximation and ligation in the gastrointestinal tract.

The ACE™ Stapler is a surgical stapler used in hospitals or surgery centers for staple closure on the wall of the stomach or gastrointestinal tract. The single-patient-use, disposable stapler head is supplied non-sterile and is fitted with a sterile, single-use staple cartridge. The stapler head is attached to a reusable, flexible stapler handle that controls the position and articulation of the stapler head. In use, the stapler is introduced into the patient through the mouth. A flexible endoscope passes through the stapler for gastric tissue visualization. The stapler works in conjunction with a vacuum pump to create a plication [tissue fold] in the GI tract, which is then compressed. The stapler then places a double, circular row of titanium staples. A non-absorbable ring helps reinforce the staple placement in the tissue. The tissue compression and stapling functions are controlled by commercially available inflation syringes. The stapler may be introduced over a guidewire. If multiple plications are required, an endogastric overtube may be used to protect the esophageal tissues during repeated insertions of the device. The guidewire, overtube, flexible endoscope, vacuum pump and inflation syringes used with the stapler are all commercially available medical devices, not the subject of this 510(k), and are not supplied with the stapler.

The BaroSense ACE Stapler is indicated for endoluminal trans-oral tissue approximation and ligation in the gastrointestinal tract.

The ACE™ Stapler is a single use, disposable, surgical stapler used in hospitals or surgery centers to create a plication of the wall of the stomach or lower esophagus. The stapler is supplied non-sterile and is fitted with a sterile, single-use staple cartridge. In use, the stapler is introduced into the patient through the mouth using a disposable endogastric tube. A flexible endoscope passes through the stapler for gastric tissue visualization. The stapler works in conjunction with a vacuum pump to create a plication of the GI tract, which is then held in place by means of a double, circular row of titanium staples delivered by the stapler (along with a non- absorbable ring to help reinforce the staple placement in the tissue). The endogastric tube, flexible endoscope and vacuum pump used with the stapler are all standard medical devices and are not supplied with the stapler.

The BaroSense EGT is indicated for use with an endoscope where multiple endoscopic intubations are anticipated.

The BaroSense EGT is a single use, disposable, overtube used in hospitals or surgery centers to provide a channel for the delivery and removal of endoscopic devices from the mouth to the stomach. It is intended for use when multiple endoscopic intubations, or endoscopic instrument/tool exchanges, are anticipated. The EGT is supplied non-sterile and is provided with a removable, flexible introducer with a tapered tip that assists in introduction of the EGT through the mouth and esophagus.