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The Intuitive Surgical da Vinci SP SureForm 45 Stapler, SP SureForm 45 Curved-Tip Stapler, and SureForm 45 Reloads and other accessories are intended to be used with the da Vinci SP Surgical System for resection, transection, and/or creation of anastomoses in Urologic, Thoracic, and Colorectal surgery.

The da Vinci SP SureForm 45 Curved Tip Stapler and da Vinci SP SureForm 45 Stapler, with the existing SureForm 45 Reloads (cleared via K183224 and K190999) are designed for use exclusively with compatible Intuitive da Vinci SP Surgical Systems (Model SP1098). It is intended for resection, transection and/or creation of anastomoses in surgery. The instrument achieves its intended use by placing multiple staggered rows of implantable staples in the target tissues (stapling) followed by cutting of the target tissue along the middle of the staple line (transection). The SP SureForm 45 Curved Tip Stapler and SP SureForm 45 Stapler Instruments are disposable, fully wristed articulating devices and are compatible with the existing, Intuitive manufactured SureForm 45 mm Gray, White, Blue, Green, and Black reloads (hereinafter referred to as SureForm 45 Reloads). The SP SureForm 45 Reloads consist of a single-use cartridge that contains multiple, staggered rows of implantable staples, and a stainless-steel knife.

The Signia™ stapler, when used with the Signia™ circular adapters and Tri-Staple™ 2.0 circular single use reloads, has applications throughout the alimentary tract for the creation of end-to-side, and side-to-side anastomoses in both open and laparoscopic surgeries.

The Signia™ circular adapters are reusable instruments that connect with the assembled Signia™ power handle and Signia™ power shell to make up the Signia™ stapler. The Signia™ circular adapters are composed of motor-mating connectors, sensor gauges and device communication interfaces to provide functionality and communication between compatible reloads and the Signia™ circular adapters are available in two shaft lengths, standard (25 cm) and extra-long (30 cm). The Signia™ Circular Adapter are for use with the Signia™ stapler, when used with the Signia™ circular adapters and Tri-Staple™ 2.0 circular single use reloads, is a battery powered microprocessor controlled surgical stapler that provides push-button powered operations and firing of compatible reloads. The Signia™ stapler is intended to be used by medical professionals qualified in the transportation, preparation, cleaning, sterilization, and use of surgical devices. The Signia™ stapler is intended for use in a sterile operating room environment in surgical procedures where surgical stapling is indicated. Signia™ Stapler can be used for both linear and circular stapling application depending on the software version installed in the Signia™ power handle.

The ECHELON™ 3000 and ECHELON ENDOPATH™ families of staplers and reloads are intended for transection, resection, and/or creation of anastomoses. The instruments have applications in multiple open or minimally invasive general, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue reinforcement materials. The instruments may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney, and spleen.

The ECHELON™ 3000 45mm and 60mm Staplers are intended for transection, resection, and/or creation of anastomoses. The instruments have applications in multiple open or minimally invasive general, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue reinforcement materials. The instruments may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney, and spleen. The ECHELON™ 3000 Staplers are sterile, single-patient use instruments that simultaneously cut and staple tissue. There are six staggered rows of staples, three on either side of the cut line. The devices are available in two different configurations (ECHELON™ 3000 45mm Staplers and ECHELON™ 3000 60mm Staplers) and three different shaft lengths (Compact, Standard, and Long). The device utilizes battery power to fire the device. The instruments are packaged with a primary lithium battery pack that must be installed prior to use. There are specific requirements for disposing of the battery pack noted in the Instructions for Use Battery Pack Disposal section of the package insert. The instruments are packaged without a reload and must be loaded prior to use. A staple retaining cap on the reload protects the staple leg points during shipping and transportation. The instrument lock-out feature is designed to prevent a used or improperly installed reload from being re-fired or an instrument from being fired without a reload.

The AEON Endoscopic Powered Stapler has applications in general, abdominal, gynecologic, and pediatric surgery for resection, transection, and creation of anastomoses. The instrument may be used for transection of liver substance, hepatic vasculature, biliary structures, pancreas, kidney and spleen.

The AEON Endoscopic Powered Stapler system is an endoscopic linear cutter and reload system that simultaneously cut and staple tissue. The AEON Endoscopic Powered Stapler places two, triple-staggered rows of titanium staples while simultaneously transecting between the two triple-staggered rows of staples. The AEON Endoscopic Powered Stapler system is composed of an AEON Endoscopic Powered Stapler Handle and the AEON Endoscopic Stapler Reloads. Multiple staple handle lengths and multiple staple sizes are available to accommodate various tissue thicknesses. The AEON Endoscopic Powered Stapler uses software to control operation of the stapler and is AC powered. The device is sterile packaged (Ethylene Oxide) and single use. The AEON Endoscopic Powered Stapler Handle may be reloaded and fired up to 20 times in a single procedure.

The GIATM stapler with Tri-Staple™ technology has applications in abdominal and thoracic surgical procedures for resection, transection and creation of anastomosis.

The GIA™ stapler with Tri-Staple™ technology places two triple staggered rows of titanium staples and simultaneously cuts and divides tissue between these two triple rows. The GIA™ staplers and cartridges with Tri-Staple™ technology are currently available in 60mm and 80 mm length. The subject device provides the thin/medium staple size. Staplers for thin/medium tissue (tan) deploy three height-progressive rows of 2.4 mm, 2.7 mm and 3.0 mm titanium staples. Each GIA™ stapler with Tri-Staple™ technology may be reloaded with a GIAT™ Cartridge with Tri-Staple™ Technology up to 7 times for a total of 8 firings per instrument. The GIA™ Stapler with Tri-Staple™ Technology is a single-use device. It is packaged and sterilized via ETO (ethylene oxide) with a 5-year shelf life, and intended for multiple use during a single procedure.

The TA™ Stapler with DST Series™ technology is indicated for use in abdominal and thoracic surgical procedures for transection or resection of tissue. The intended purpose of the device is the application of staples for the purpose of tissue approximation and is limited to the aspect of stapling the tissue to prepare for the transection and resection of tissue.

The TA™ Stapler with DST Series™ Technology with a TA™ Loading Unit with DST Series™ Technology is a modular stapling system indicated for use during transection of tissue during surgical procedures. The TA™ Stapler is a handheld mechanical stapler handle used to position and deploy TA™ Loading Units, which are staple cartridges containing titanium staples. The TA™ staplers and TA™ Loading Units are supplied sterile. To perform its intended use, the distal shaft of a TA™ Stapler is assembled with a TA™ loading unit. The TA™ Stapler acts as a stapler handle used by the surgeon to insert and position the TA™ Loading Units inside the body via an incision. The TA™ Loading Unit is then mechanically activated by the surgeon by squeezing the handle of the TA™ stapler, thereby deploying staggered rows of titanium staples to close incisions in abdominal and thoracic tissue. The TA™ Stapler is reloadable meaning the surgeon can manually remove a fired TA™ Loading Unit and replace it with a new TA™ Loading Unit for subsequent firing in a single patient surgical procedure. The TA™ Stapler can be reloaded up to 7 times for a total of 8 firings per instrument. The TA™ Staplers with DST Series™ Technology are available with staple line anvil lengths that accommodate 30, 45, 60 and 90 mm length TA™ Loading Units. The TA™ Loading Unit with DST Series™ Technology are available with staple heights of 2.5 mm (white vascular cartridge, 3 rows of staples, 30 mm length only); 3.5 mm (blue cartridge, 2 rows of staples, 30, 45, 60 and 90 mm lengths); 4.8 mm (green cartridge, 2 rows of staples, 30, 45, 60 and 90 mm lengths). The TA™ Loading Unit with DST Series™ Technology and TA™ Staplers with DST Series™ Technology are intended to be used by medical professionals qualified in the transportation, preparation, and use of surgical devices. The TA™ Loading Unit with DST Series™ Technology and TA™ Staplers with DST Series™ Technology are intended for use in a sterile operating room environment in surgical procedures where surgical stapling is indicated.

The EEA™ Circular Stapler with Tri-Staple™ Technology and OrVil™ transoral circular stapler anvil have application throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries.

The EEA™ circular stapler with Tri-Staple™ technology and OrVil™ Transoral Circular Stapler Anvil is a manual, single-use device that places a circular, triple staggered row of titanium staples and resects the excess tissue. It has application throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries. The subject device is to add new product models with OrVil™ transoral circular stapler anvil to EEA™ circular stapler with Tri-Staple™ technology 21mm or 25mm XL purple or black stapler.

The Signia™ stapler, when used with the Signia™ circular adapters and Tri-Staple™ 2.0 circular single use reloads, has applications throughout the alimentary tract for the creation of end-to-side, and side-to-side anastomoses in both open and laparoscopic surgeries.

The Tri-Staple™ 2.0 black circular reloads place a circular triple staggered row of titanium staples. After staple formation, the knife blade resects the excess tissue, creating a circular anastomosis such as endto-end, end-to-side, or side-to-side anastomosis as the user sees fit. The new circular reloads will be offered for an extra thick tissue thick is identified by the black staple quide. The circular reloads deploy three height-progressive rows of 4.0 mm. 4.5 mm staples. The Tri-Staple™ technology incorporated in the black reload is essentially the same as the legally-marketed K192330 in terms of reload design. The Tri-Staple™ 2.0 black circular reloads are provided sterile for single use, and available in three lumen sizes: 28, 31, and 33 mm. The Tilt-Top™ anvil is available with all circular reloads. The Tri-Staple™ 2.0 black reloads are for use with the previously-marketed Signia™ Circular Adapter. as part of the Signia™ stapler. The Signia™ stapler, when used with the Signia™ circular adapters and Tri-Staple™ 2.0 circular single use reloads, is a battery powered microprocessor controlled surgical stapler that provides push-button powered operations and firing of compatible reloads.

The ECHELON FLEX™, ECHELON™ 3000, and ECHELON ENDOPATH™ families of staplers and reloads are intended for transection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue reinforcement materials. The instruments may also be used for transection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.

The ECHELONTM 3000 45 mm and 60 mm Staplers are sterile, single-patient-use instruments that simultaneously cut and staple tissue. There are six staggered rows of staples, three on either side of the cut line. The ECHELON™ 3000 45 mm Staplers have a staple line that is approximately 45 mm long and a cut line that is approximately 42 mm long. The ECHELON™ 3000 60 mm Staplers have a staple line that is approximately 60 mm long and a cut line that is approximately 57 mm long. The shaft can rotate freely in both directions and an articulation mechanism enables the distal portion of the shaft to pivot to facilitate lateral access to the operative site. The instruments are packaged with a primary lithium battery pack that must be installed prior to use. There are specific requirements for disposing of the battery pack. Refer to the Battery Pack Disposal section. The instruments are packaged without a reload and must be loaded prior to use. A staple retaining cap on the reload protects the staple leg points during shipping and transportation. The instruments' lock-out feature is designed to prevent a used or improperly installed reload from being refired or an instrument from being fired without a reload.