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Standard Staple-Line Reinforcement is indicated for use in bariatric procedures in which gastric tissue transection and resection with staple line reinforcement is needed.

The Standard Staple-Line Reinforcement (SSLR23) is an implantable device designed to be used with Standard Bariatrics' TITAN SGS23R device (K210278) during laparoscopic surgery to position, clamp, staple, and resect long planes of soft flat tissue and organs, such as the stomach. The SSLR23 device consists of 2 (two) sheets of GORE® SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material, configured to be used only with TITAN SGS23R and which provides a continuous sheet of Staple-Line Reinforcement for the entire length of the staple-line, up to 23cm in length. The device contains an applicator to aid in the installation of the SSLR23 on the TITAN SGS23R jaws. The SSLR23 device is single-use and supplied sterile.

The Standard Tapered Bougie, 38Fr (STB38) is indicated for use in conjunction with the Titan SGS® Stapler in vertical sleeve gastrectomy pouch creation for the application, stomach decompression, drainage of gastric fluids, irrigation and insufflation, and to serve as a sizing guide.

The Standard Tapered Bougie, 38Fr (STB38) is a non-sterile, single patient use device. The device comprises a tube with a rounded tip featuring drainage holes, and a tapered balloon at the distal end. The proximal end of the Standard Tapered Bougie, 38Fr (STB38) includes a standard Luer lock valve for balloon inflation/deflation using the 60mL/CC syringe (provided) and a 7.5mm inner diameter straight tube for connection to operating room suction, Standard Bougie Hand Pump (SBHP) or tapered tip syringe.

The STANDARD BOUGIE SB38 is indicated for use in conjunction with the Titan SGS stapler in vertical sleeve gastrectomy pouch creation for the application of suction, stomach decompression, drainage of gastric fluids, irrigation and insufflation, and to serve as a sizing guide.

The Standard Bougie (SB38) is a single patient use, non-sterile device which consists of an 80 cm long, 38 French (38 Fr) diameter tube with a luer connector at the proximal end of the tube has multiple holes and a rounded end. At the distal end is a balloon that can be inflated with water or saline to be used as a sizing guide. The device is used to decompress the stomach, remove stomach contents, and allow for irrigation and insufflation via the distal holes. The balloon is inflated and deflated as desired by connecting a syringe to the luer connector at the proximal end and injecting water into the balloon. The tube and balloon serve as a sizing guide. The Standard Bougie Hand Pump (SBHP) is an accessory to the current Standard Bougie (SB38). The SBHP is provided to enable insufflation of the stomach to enable controlled rearrangement of the gastric folds/rugae of the stomach or to perform leak testing during gastric and bariatric procedures.

The STANDARD BOUGIE™ SB38 is indicated for use in conjunction with the Titan SGS ™ stapler in vertical sleve gastrectorny pouch creation for the application of suction, stomach decompression, drainage of gastric fluids, irrigation and insufflation, and to serve as a sizing guide.

The Standard Bougie SB38 is a single patient use, non-sterile device which consists of an 80 cm long, 38 French (38 Fr) diameter tube with a luer connector at the proximal end of the tube has multiple holes and a rounded end. At the distal end is a balloon that can be inflated with water or saline to be used as a sizing guide. The device is used to decompress the stomach, remove stomach contents, and allow for irrigation and insufflation via the distal holes. The balloon is inflated and deflated as desired by connecting a syringe to the luer connector at the proximal end and injecting water into the balloon. The tube and balloon serve as a sizing guide.

The Titan SGS linear cutter is intended for longitudinal transection of gastric tissue for sleeve gastrectomy pouch creation.

The Titan SGS with implantable staples (Titan Stapler) is a single patient use, sterile instrument used for cutting and stapling gastric tissue for sleeve gastrectomy pouch creation. The Titan Stapler is supplied preloaded with staples, fires once and cannot be reloaded. The Titan Stapler is comprised of three main sections: Stapler, Cable, and Power Supply Unit. The stapler end effector is 230 mm long and contains 342 staples that are organized in 6 staggered rows, 3 on each side of the cut line. The staples range in closed staple height from 2.2 mm to 1.2 mm. Staples are formed into a traditional 'B' shape: similar to existing devices. As with other powered staylers, the Titan Stapler opens and closes through a simple mechanical linkage housed in the shaft and effector of the device. The device of the single-use Titan Stapler and a reusable power source which is supplied separately. There are no accessories supplied with the instrument. The Titan Stapler Power Source is designed to supply energy to the Titan Stapler and has a unique receptable port specific to the Titan Stapler.

The Standard Trocar is a sterile, single-use device consisting of an obturator, a cannula, a 5mm adapter and introducer sheath. This system is indicated for use in general and abdominal minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments.

The Standard Trocar is a single-patient-use disposable trocar manufactured from biocompatible medical plastics. The device is comprised of a trocar cannula, obturator, 5 mm adaptor, and introducer sheath. The Standard Trocar is a sterile, single patient use surgical instrument intended to establish a port of entry for 19mm outer diameter instruments to be used during minimally invasive procedures. The 5 mm adaptor provides the means for the trocar to also be used with 5 mm diameter instruments. The trocar is compatible with commercially available laparoscopic instruments. In addition, as Standard Bariatrics develops additional laparoscopic instruments, the Standard Trocar will accommodate those devices. The Standard Trocar is sterilized using gamma irradiation and provided to the user in a Tyvek tray with peel lid.

The STANDARD BOUGIE® is indicated for use in conjunction with the STANDARD CLAMP® in vertical sleeve gastrectomy procedures for the application of suction, stomach decompression, drainage of gastric fluids, irrigation and to serve as a sizing guide.

The Standard Bougie is a single patient use, non-sterile device which consists of an 80 cm long, 18 French diameter tube with a luer connector at the proximal end of the tube has multiple holes and a rounded end. At the distal end is a balloon that can be inflated with water or saline to be used as a sizing guide. The device is used to decompress the stomach contents, and allow for irrigation via the distal holes. The balloon is inflated and deflated as desired by connecting a syringe to the luer connector at the proximal end and injecting water into the balloon. The tube and balloon serve as a sizing guide.

The Standard Clamp, Disposable is indicated for use in laparoscopic procedures to grasp, clamp, and manipulate soft tissues. The Clamp is indicated for use in bariatric procedures such as sleeve gastrectomy as a guide, to clamp and manipulate flat tissue and organs, such as the stomach.

The Standard Clamp, Disposable is a disposable non-energized, hand held surgical instrument designed for use in laparoscopic procedures to clamp long planes of soft tissue such as the stomach. The Standard Clamp, Disposable is provided sterile (gamma). There are no accessories provided with the device. The instrument is comprised of three main sections: handle, shaft, and end effector. The handle is a pistol grip with a trigger and release button which are manually activated in order to open and close the end effector. The shaft is sized to fit a standard 12 mm trocar. The clamp is comprised of an upper and lower jaw that close to grasp and hold tissue. The environment of use is in a hospital during laparoscopic surgical procedures. The current Standard Clamp, Disposable has a jaw length of 25 cm. This Special 510(k) is being filed to add a new shorter jaw length (22 cm) to accommodate patients with smaller abdomens. The Standard Clamp, Disposable is intended to be used by a surgeon on a single patient during a single laparoscopic surgery under normal operating conditions. The Standard Clamp, Disposable is intended to be inserted into the peritoneal cavity through a 12mm trocar and used in up to six cycles of opening and closure to grasp, clamp and manipulate long, 1.2 to 4.5mm thick, planes of soft tissues such as the stomach. The Standard Clamp, Disposable is not intended for direct contact with the cardiovascular system, lymphatic system or cerebrospinal fluid. The Standard Clamp, Disposable can be used while a surgeon uses devices such as a stapler adjacent to tissue that is clamped with the Standard Clamp, Disposable, e.g., to help guide endoscopic staplers during resection of tissue such as in sleeve gastrectomy.

The Standard Clamp, Disposable is indicated for use in laparoscopic procedures to grasp, clamp, and manipulate soft tissues. The Clamp is indicated for use in bariatric procedures such as sleeve gastrectomy as a guide, to clamp and manipulate flat tissue and organs, such as the stomach.

The Standard Clamp, Disposable is a disposable non-energized, hand held surgical instrument designed for use in laparoscopic procedures to clamp long planes of soft tissue such as the stomach. The Standard Clamp, Disposable is provided sterile (gamma). There are no accessories provided with the device. The instrument is comprised of three main sections: handle, shaft, and end effector. The handle is a pistol grip with a trigger and release button which are manually activated in order to open and close the end effector. The shaft is sized to fit a standard 12 mm trocar. The end effector of the clamp is comprised of an upper and lower jaw that close to grasp and hold tissue. The environment of use is in a hospital during laparoscopic surgical procedures.

The Standard Clamp, Disposable is indicated for use in laparoscopic procedures to grasp, clamp, and manipulate soft tissues.

The Standard Clamp, Disposable is a disposable non-energized, hand held surgical instrument designed for use in laparoscopic procedures to clamp long planes of soft tissue such as the standard Clamp, Disposable is provided sterile (gamma). There are no accessories provided with the device. The instrument is comprised of three main sections: handle, shaft, and end effector. The handle is a pistol grip with a trigger and release button which are manually activated in order to open and close the end effector. The shaft is sized to fit a standard 12 mm trocar. The end effector of the clamp is comprised of an upper and lower jaw that close to grasp and hold tissue. The environment of use is in a hospital during laparoscopic surgical procedures.