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The iDrive Intelligent Power Unit with iConsole, when used with: a) compatible Intelligent Surgical Instrument Linear Staplers , have applications for general and endoscopic surgery in gastrointestinal, gynecological, general abdominal, and thoracic surgical procedures for resection, transection, creation of anastomoses, and for open occlusion of the heart's left atrial appendage. b) compatible Intelligent Delivery Systems (iStraight, iFlex, iCurve) and Right Angle or Power Linear Cutter Digital Loading Units®, has applications in gastrointestinal, gynecological, general abdominal, and thoracic surgical procedures for resection, transection, and creation of anastomoses. c) compatible Intelligent Delivery Systems and Circular Stapler Digital Loading Units®, has applications for use throughout the alimentary tract for end-to-end, end-to-side, and side-to-side anastomoses. d) compatible Vascular Intelligent Surgical Instruments or Intelligent Delivery Systems with Vascular Digital Loading Units®, has applications for general and endoscopic surgery including multiple open and minimally invasive general, gynecological, urologic (including radical prostatectomy), thoracic, and pediatric surgical procedures for resection, transection, and/or creation of anastomoses. They can be used with staple line buttressing material such as bovine pericardium.

The iDrive with iConsole is used in conjunction with the Intelligent Delivery Systems and Intelligent Surgical Instruments in order to resect tissue, transect tissue and create anastomoses between structures. The iDrive was previously cleared to market via K073001 and was subsequently cleared to market with additional vascular indications via K073148. The iDrive is a handpiece with integrated controls that operate the attached Intelligent Delivery Systems and Intelligent Surgical Instruments.

The Intelligent Articulating Endoscopic Linear Cutters Reverse with Reloads have applications for general and endoscopic surgery in gastrointestinal, gynecological, general abdomihal and thoracic surgical procedures for resection, transection, and creation of anastomoses.

The Intelligent Articulating Endoscopic Linear Cutter Reverse with Reloads has identical technological features as the predicate device, i45/160 (K071708). The modification made to the device was that the pivot point for the jaws was translated distally, which enables the device to open in Reverse. Both the subject device and the predicate device deliver stapling/cutting action to create anastomoses.

The Intelligent Articulating and Straight Endoscopic Linear Cutters -- Vascular with Reloads have applications for general and endoscopic surgery including multiple open or minimally invasive general, gynecological, urologic (including radical prostatectomy) thoracic, and pediatric surgical procedures for transaction, resection, and/or creation of anastomoses. They can be used with staple line or tissue buttressing material such as bovine pericardium.

The Intelligent Articulating and Straight Endoscopic Linear Cutters - Vascular with Reloads are reusable, articulating and non-articulating, handheld vascular surgical staplers. The devices are supplied non-sterile and must be cleaned and sterilized prior to use. The device creates a linear transection with three staggered rows of titanium staples on each side of the cutting blade.

The illifies/20tives/20tiveF, when used with compatible Linear Digital Loading Units®, has applications for general and endoscopic surgery in gastrointestinal, gynecological, general abdominal, and thoracic surgical procedures for resection, transection, creation of anastomoses, and for open occlusion of the heart's left atrial appendage. The annives/iDrivell/iDriveF, when used with compatible Right Angle Linear Cutter Digital Loading Units®, has applications in gastrointestinal, gynecological, general abdominal, and thoracic surgical procedures for resection, transection, and creation of anastomoses. The illifies/40riveF/ infore, when used with compatible Circular Digital Loading Units®, has applications for use throughout the alimentary tract for end-to-end, end- to-side, and side-to-side anastomoses.

The iDrive is a reusable, hand-held medical device that is used to operate various SuraASSIST® Digital Loading Units® (DLUs), all of which were previously cleared to market. The iDrive consists of a handpiece with integrated controls that operate the DLUs.

The iDriveS/iDrive&/iDriveF, when used with compatible Vascular Digital Loading Units®, have applications for general and endoscopic surgery including multiple open and minimally invasive general, gynecological, urologic (including radical prostatectomy), thoracic, and pediatric surgical procedures for resection, fransection, and/or creation of anastomoses. They can be used with staple line or buttressing material such as bovine pericardium.

The iDrive is a reusable, hand-held medical device that is used to operate various SurgASSIST® Digital Loading Units® (DLUs), all of which were previously cleared to market. The iDrive consists of a handpiece with integrated controls that operate the DLUs.

The i45, i45s, i60, i60s have applications for general and endoscopic surgery in gastrointestinal, gynecological, general abdominal, thoracic surgical procedures for resection, transection, creation of anastomoses, and for open occlusion of the heart's left atrial appendage.

The devices described here are reusable i45, i45S, i60, i60S used in conjunction with a variety of Reloads, which were previously cleared to market under K052415. The i45, i45S, i60, i60S are designed to be cleaned and sterilized for multi-patient use. The i45, i45S, i60, i60S is an integrated stapler that articulates left and right. In addition to motors for stapling and cutting, and articulation, the proximal housing holds the battery and electronics enabling untethered use. Device control is managed with buttons and rocker switches on the proximal housing. The device will be steam sterilized. All product patient contact materials adhere to industry standards.

The Power Extenders have applications for general and endoscopic surgery in gastrointestinal, gynecological, general abdominal, and thoracic surgical procedures for resection, transection, creation of anastomoses, and for open occlusion of the heart's left atrial appendage.

The Power Extenders are components of the SuraASSIST® System. A hand-held medical instrument, which connects the FlexShaft and Digital Loading Units® (DLUs) providing rigid capability, longitudinal positioning and mechanical interface of the DLU during surgical procedures. Power Extenders serve as a conduit between the DLUs and the Power Console. They obtain the mechanical and electrical power from the PC100 via the FlexShaft. Internally, the instrument contains drive-shafts that couple with the driveshafts in the FlexShaft. Rotary motion provided by the motors (located in the PC100) is delivered to the instrument through these drive shafts for various purposes such as clamping tissue or forming staples with attached DLUs.

The Natural Orifice Linear Cutter Digital Loading Units® with Reloads have applications for general and endoscopic surgery in gastrointestinal, gynecological, general abdominal, and thoracic surgical procedures for resection, transection, creation of anastomoses, and for open occlusion of the heart's left atrial appendage.

The device described here is a Natural Orifice Linear Cutter Digital Loading Unit ® used in gastrointestinal, gynecological, thoracic, bariatric and other surgeries for resections, transections and the creation of anastomoses.

The Power Circular Stapler Digital Loading Units® have applications throughout the alimentary tract for end-to-end, end-to-side, and side-to-side anastomoses.

Power Circular Stapler Digital Loading Units® are single use, disposable, surgical stapling devices designed for creating a circular anastomosis between two tubular structures and/or tissue layers.

The Power Right Angle Linear Cutter Digital Loading Units® have applications in gastrointestinal, gynecological, and general abdominal and thoracic surgical procedures for resection, transection, and creation of anastomoses.

The device described here is a Power Right Angle Linear Cutter Digital Loading Unit® used in gastrointestinal, gynecological, thoracic, bariatric and other surgeries for resections, transactions and the creation of anastomoses. The Power Right Angle Linear Cutter Digital Loading Unit® cuts and staples identically to the predicate devices (K021701 and K012809). The Power Right Angle Linear Cutter Digital Loading Unit® was modified to enhance ease of use. This new design enables the anvil to swivel 90 degrees once the DLU is opened beyond 16 mm, allowing the user to work in confined anatomical areas.