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The Levita Magnetic Surgical System is designed to grasp and retract the body and the fundus of the gallbladder in laparoscopic cholecystectomy procedures; the liver in bariatric procedures; the pillar of the diaphragm and peripillar tissue in bariatric or hiatal hernia procedures; the prostate and periprostatic tissue in prostatectomy procedures; and the colon, rectum, and pericolorectal tissue in colorectal procedures to facilitate access and visualization of the surgical site. The device is indicated for use in patients with a BMI range of 20-60-kg/m2. The Grasper Tip, 12.5 is designed to grasp and retract the pillar of the diaphragm and peripillar tissue in bariatric or hiatal hernia procedures to facilitate access and visualization of the surgical site. The device is indicated for use in patients with a BMI range of 20-60 kg/m2.

The Magnetic Surgical System comprises two hand-held instruments, the Magnetic Grasper and the external Magnetic Controller. The Magnetic Grasper, disposable and provided sterile for single use, comprises two main components: a detachable Grasper Tip (6.5cm overall length) and a Shaft with Handle. An optional 12.5cm length Grasper Tip (also single use, disposable, and provided sterile) may be used as a replacement for the 6.5cm Grasper Tip and can be used interchangeably with the Shaft. The Magnetic Grasper is actuated via its pistol-grip handle with two distinct scissor-type motions to open and close the Grasper Tip jaws. Once the Magnetic Grasper is inserted through a compatible ≥ 10 mm laparoscopic port to the surgical site and the Grasper Tip is attached to the desired tissue, the Grasper Tip can be detached from the Shaft and controlled externally using the Magnetic Controller. Traction of the tissue is maintained through the magnetic field attraction between the Grasper Tip and the Magnetic Controller. The Magnetic Controller is a non-sterile, reusable unit with handles that is held external to the body and emits a magnetic field that attracts the detachable Grasper Tip. Once the Grasper Tip is attached to the desired tissue and detached from the Shaft, the Magnetic Controller is placed external to the body to magnetically attract the Grasper Tip to manipulate the target tissue. Adjusting the distance between the Magnetic Controller and the Grasper Tip will modulate the magnetic attraction used for tissue retraction/mobilization. If desired, the user can connect the Magnetic Controller to a commercially available surgical support arm that is compatible with its arm mount.

The Surgeon Controlled Arm is indicated for use to hold and position a rigid laparoscope/endoscope and the Magnetic Controller of the Levita Magnetic Surgical System in minimally invasive interventions where the Levita Magnetic Surgical System is indicated for use.

The Surgeon Controlled Arm for the Levita Magnetic Surgical System (MSS) comprises two collaborative surgeon-controlled arms, which along with their controllers, control software, and custom attachments, are intended to hold and control the Magnetic Controller of the commercially available MSS (most recently cleared under K191762) using an arm and to hold and control a commercially available endoscope with camera using the second arm. The design of the surgeon-controlled arms, referred to as the Scope Arm and the Magnet Arm, includes several redundant safety features that make them well suited for use with the MSS in the operating room environment, including hardware and software safety controls. When mounted on the Scope Arm, an endoscope can be pivoted and translated as controlled by the user, while maintaining minimal motion at the point where the endoscope enters the patient's body via a standard trocar. Similarly, when mounted on the Magnet Arm, the Magnetic Controller can be moved to different positions on or away from the abdominal wall. The Surgeon Controlled Arm includes the following components: - (1) Two Carts, which are the Scope Cart and the Magnet Cart. Each Cart includes a surgeoncontrolled arm mounted on top of a moveable cart with custom attachments. One arm functions as a Scope Arm to hold a commercially available endoscope with endoscopic camera. The other arm functions as a Magnet Arm and includes a Magnet Holder to hold the Magnetic Controller of the MSS; - (2) a Scope Holder for attachment and detachment of a compatible commercially-available endoscope to the end of the Scope Arm: - (3) a Foot Controller for foot-actuated selection of the active arm and foot-actuated remote control for one of the arms at a time; - (4) custom-programmed software, the Levita Custom Control Software Program. The Surgeon Controlled Arm provides for computer control of a dual- arm device with motorized axes to hold and control the movements of a rigid endoscope and the Magnetic Controller of the Levita MSS during the minimally-invasive procedures cleared for the MSS (most recently cleared under K191762). The user selects the active arm and controls its movement using a Foot Controller. Only one arm is enabled for computer-controlled movement at any given time; while one arm is being moved, the other arm remains stationary. The user may also manually move the arms (i.e. hand guiding) at any time without the use of the Foot Controller. For the Scope Arm, the reference point for scope movement is established as the Trocar Point and is set by the user, who positions the endoscope near the trocar inserted in the body opening (e.g. the abdominal fascial layer) and presses the Teach Trocar button on the Scope Adaptor. The Custom Control Software Program then calculates the required individual movements of the Scope Arm motorized axes relative to the Trocar Point in order to achieve the desired total movement of the endoscope with respect to the endoscope view. Once the Custom Control Software Program completes the Teach Trocar procedure, the Foot Controller is enabled, allowing the user in a standing position by the operating table to direct endoscope movement by using their foot to press on switches corresponding to the allowed movement directions. For the Magnet Arm, the same arm hardware, software, and Foot Controller are employed to move the Magnetic Controller also in the same directions.

The Levita Magnetic Surgical System is designed to grasp and retract the body and the fundus of the gallbladder in laparoscopic cholecystectomy procedures; the liver in bariatric procedures; the prostate and periprostatic tissue in prostatectomy procedures; and the colon, rectum, and pericolorectal procedures to facilitate access and visualization of the surgical site. The device is indicated for use in patients with a BMI range of 20-60-kg/m².

The Levita Magnetic Surgical System is composed of two hand-held instruments, the Magnetic Grasper and external Magnetic Controller. The Magnetic Grasper (sterile, single use), comprised of a distal detachable Grasper Tip attached to a Shaft with handle, is actuated via its pistol-grip handle with two distinct scissor-type motions to open and close the detachable Grasper Tip jaws. Once the Magnetic Grasper is inserted through a compatible ≥ 10 mm laparoscopic port and the Grasper Tip is attached to the desired tissue, the Grasper Tip can be detached from the Shaft and controlled externally using the Magnetic Controller. Traction of the tissue is maintained through the magnetic field attraction between the Grasper Tip and the Magnetic Controller. The Magnetic Controller (non-sterile, reusable) is a single unit with handles that is held external to the body and emits a magnetic field that attracts the Grasper Tip. Once the Grasper Tip is attached to the desired tissue and detached from the Shaft, the Magnetic Controller is placed external to the body to magnetically attract the Grasper Tip to manipulate the target tissue. Adjusting the distance between the Magnetic Controller and the Grasper Tip will modulate the magnetic attraction used for tissue retraction/mobilization. If desired, the user can connect the Magnetic Controller to a commercially available surgical support arm that is compatible with its arm mount.

The Levita Magnetic Surgical System is designed to grasp and retract the body and the fundus of the gallbladder in laparoscopic cholecystectomy procedures, the liver in bariatric procedures, and the prostatic tissue in prostatectomy procedures to facilitate access and visualization of the surgical site. The in patients with a BMI range of 20-60 kg/m2.

The Levita Magnetic Surgical System is composed of two hand-held instruments, the Magnetic Grasper and external Magnetic Controller. The Magnetic Grasper (sterile, single use), comprised of a distal detachable Grasper Tip attached to a Shaft with handle, is actuated via its pistol-grip handle with two distinct scissor-type motions to open and close the detachable Grasper Tip jaws. Once the Magnetic Grasper is inserted through a compatible The Magnetic Controller (non-sterile, reusable) is a single unit with handles that is held external to the body and emits a magnetic field that attracts the Grasper Tip. Once the Grasper Tip is attached to the desired tissue and detached from the Shaft, the Magnetic Controller is placed external to the body to magnetically attract the Grasper Tip to manipulate the target tissue. Adjusting the distance between the Magnetic Controller and the Grasper Tip will modulate the magnetic attraction used for tissue retraction/mobilization. If desired, the user can connect the Magnetic Controller to a commercially available surgical support arm that is compatible with its arm mount.

The Magnetic Surgical System is designed to grasp and retract the body and the fundus of the gallbladder in laparoscopic cholecystectomy procedures and the liver in bariatric procedures to facilitate access and visualization of the surgical site. The device is indicated for use in patients with a BMI range of 20-60 kg/m².

The Levita Magnetic Surgical System is composed of two hand-held instruments, the Magnetic Grasper Device and external Magnetic Controller. The Magnetic Grasper Device (sterile, single use), comprised of a distal Detachable Grasper attached to a Delivery/Retrieval shaft with Handle, is actuated via its pistol-grip Handle with two distinct scissor-type motions to open and close the Detachable Grasper jaws. Once the Magnetic Grasper Device is inserted through a compatible ≥ 10 mm laparoscopic port and the Detachable Grasper is attached to the desired tissue, the Detachable Grasper can be detached from the Delivery/Retrieval Shaft and controlled externally using the Magnetic Controller. Traction of the tissue is maintained through the magnetic field attraction between the Detachable Grasper and the Magnetic Controller. The Magnetic Controller (non-sterile, reusable) is a single unit with handles that is held external to the body and emits a magnetic field that attracts the Detachable Grasper. Once the Detachable Grasper is attached to the desired tissue and detached from the Delivery/Retrieval Shaft, the Magnetic Controller is placed external to the body to magnetically attract the Detachable Grasper to manipulate the target tissue. Adjusting the distance between the Magnetic Controller and the Detachable Grasper will modulate the magnetic attraction used for tissue retraction/mobilization. If desired, the user can connect the Magnetic Controller to a commercially available surgical support arm that is compatible with its arm mount.

The Magnetic Surgical System is designed to grasp and retract the body and the fundus of the gallbladder in laparoscopic cholecystectomy procedures to facilitate access and visualization of the surgical site. The device is indicated for use in patients within a BMI range of 20 to 34 kg/m².

The Magnetic Surgical System is composed of two hand-held instruments: a Magnetic Grasper Device and an external Magnetic Controller. The Magnetic Grasper Device is comprised of two main components: a Detachable Grasper and a Delivery/Retrieval Shaft. Once the Magnetic Grasper Device is inserted and the Grasper is attached to the desired tissue, the Detachable Grasper can be detached from the Delivery/Retrieval Shaft and controlled externally using the Magnetic Controller. Traction of the tissue is maintained through the magnetic field attraction between the Grasper and the Magnetic Controller. The Magnetic Grasper Device is compatible with a ≥ 10 mm laparoscopic port. The Magnetic Controller is a single unit with handles that is held external to the body and emits a magnetic field that attracts the Detachable Grasper. Once the Detachable Grasper is attached to the desired tissue and detached from the Delivery/Retrieval Shaft, the Magnetic Controller is placed external to the body to magnetically attract the Grasper to manipulate the target tissue. Adjusting the distance between the Magnetic Controller and the Detachable Grasper will modulate the magnetic attraction used for tissue retraction/manipulation.

The Levita Magnetic Surgical System is designed to grasp and retract the body and the fundus of the gallbladder in laparoscopic cholecystectomy procedures to facilitate access and visualization of the surgical site. The device is indicated for use in patients within a BMI range of 20 to 34 kg/m2.

The Levita Magnetic Surgical System is composed of two hand-held instruments, the Magnetic Grasper Device and external Magnetic Controller, which are intended to facilitate tissue grasping, retraction and mobilization during laparoscopic cholecystectomy procedures. 1. Magnetic Grasper Device (sterile, single use) is actuated via its pistol-grip handle with two distinct scissor-type motions to open and close the Detachable Grasper jaws as shown in Figure 1. At the distal end is the Detachable Grasper, which is attached to the Delivery/Retrieval Shaft of the full Magnetic Grasper Device. This device requires a >10mm access port to introduce the device into the abdominal cavity. The Detachable Grasper is then coupled (held in place within the abdomen) by the external Magnetic Controller. If the surgeon wishes to use a single 10-12 mm port at the umbilicus such as a Hasson port and that is the port shared by the optic, applying and adjusting the Detachable Grasper may require repetitive placement of the optic in an alternative port. The Detachable Grasper is shown in Figure 2. 2. An External Magnetic Controller (non-sterile, reusable) 3-inch diameter by 2-inch thick b(4) disk magnet, shown in Figure 3. This component holds the Detachable Grasper (magnetically) and is placed on the external abdomen wall.