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The Uni-port is intended to provide access for multiple instruments and/or endoscope to the abdominal cavity through a single incision during minimally invasive laparoscopic surgery.

Uni-port is a single use manual operated surgical retractor comprised of three components; main body, wound retractor and filter. The main body consist of combinations of several ports of various size (5mm, 12mm, 15mm and 28mm). The wound retractor is a flexible polyurethane film that has two rings attached at each end and a Thandle connected with thread for easily removal after procedure. The single (lower) ring is inserted into the abdomen for fixation and double (upper) ring is connected with main body. The filter is provided separately to filter out harmful gas generated in the abdominal cavity, it is easy to ensure a clear view.

The CORE-SPORT is intended to provide access for multiple instruments and/or endoscope to the abdominal cavity through a single incision during minimally invasive laparoscopic surgery.

The CORE-SPORT, an surgical instrument that provide access for multiple instruments and/or endoscope to the abdominal cavity through a single incision during minimally invasive laparoscopic surgery, and consists of a Port-Assay and a Retractor. Port-Assay consists of several ports of various sizes. Port-Assay consists of 3 or 4 ports and 5 and/or 12 mm sized ports. The proposed product is packed in Tray & Tyvek following EO Sterilization (SAL 10°). The device is supplied sterile for single-use and shall be not reused or re-sterilized.

The AFS MEDICAL's Sterile Single-Use Access Port System for surgery is a manual device designed to access the peritoneal cavity during laparoscopic surgery minimally invasive surgery. Examples of procedures where the device may be used include colorectal, urological, and general surgery to access the surgical site

The AFS MEDICAL's Sterile Single-Use Access Port System for surgery is a manual device designed to access the peritoneal cavity during laparoscopic surgery. The modular system can be used in a number of configurations as desired by the user. The system is named, JACK . System options include integrated LED lighting to provide additional intrabdominal illumination if desired, insufflation ports, and multiple cap/port options. Other device variants include retractor diameter, height, number of ports and port size configurations, number of LEDs, power line length, with disposable or external/rechargeable battery (to power light source). The device includes a receiving ring that allows for 360° rotation of the port during use.. The device includes blue light indicators on the port head to inform the user that the port head is correctly attached and sealed. The system includes Smart Tubing that contains LED lighting for additional illumination and holes connected to tubing for introduction of CO2 and removal of surgical smoke

The FMX314 Surgical Platform is composed of FMX314 Instruments that are used in minimally invasive abdominal laparoscopic surgery: - The FMX314 Introducer is intended to establish a path of entry for laparoscopic instruments for use during minimally invasive abdominal laparoscopic surgery in combination with the FMX314 Instruments. - The FMX314 Instruments are intended for use in minimally invasive abdominal laparoscopic surgical procedures for grasping, mobilizing, dissecting, cutting, cauterizing, ligating, and suction irrigation of tissues and vessels during laparoscopic procedures.

The FMX314 Surgical Platform is a single-port laparoscopic surgery platform, featuring single-use, disposable articulating surgical instruments for the purpose of doing minimally invasive abdominal laparoscopic surgery by closely mimicking multi-port laparoscopic surgery. The FMX314 Surgical Platform is composed of the reusable FMX314 Introducer, the single-use FMX314 Hub Cap & Sealing Unit, and the single-use FMX314 Instruments that are used as part of laparoscopic surgery according to the intended use. The FMX314 Surgical Platform does not require a larger diameter incision than standard laparoscopic surgery (compatible with a single, standard 15mm trocar) and will utilize currently marketed conventional 15mm laparoscopic access devices (trocars), rigid 5mm laparoscopes, and instrument compatible handles for instrument manipulation and monopolar cutting and cauterizing. The FMX314 Introducer is a reusable, single port access device for abdominal laparoscopic surgical procedures to be used in combination with a standard 15 mm trocar, FMX314 Hub Cap & Sealing Unit assembly (accessory), and the FMX314 Introducer is designed for introducer is designed for introducing, holding, supporting and guiding the FMX314 Instruments and a standard, rigid 5 mm laparoscope. The cavity at the top of the FMX314 Introducer (hub) is designed to place the single-use FMX314 Hub Cap & Sealing Unit. The FMX314 Hub Cap & Sealing Unit is designed to maintain pneumoperitoneum in the abdomen during the surgical procedure, whether or not one or more FMX314 Instruments are inserted in the instrument lumen(s) of the Introducer. Locking recesses in the hub guide the correct placement of the FMX314 Sealing Unit. The bayonet fitting at the hub is designed to properly position the single-use FMX314 Hub Cap & Sealing Unit on the FMX314 Introducer and to lock the FMX314 Sealing Unit in the hub. By turning the FMX314 Hub Cap clockwise a "click" is heard indicating that the FMX314 Hub Cap & Sealing Unit is locked into position. Prior to its reuse after completion of a procedure the FMX314 Introducer has to be disassembled and sterilized per Instructions For Use. The FMX314 Surgical Platform comprises six (6) disposable articulating laparoscopic surgical instruments (i.e. FMX314 Grasper, Maryland, Clip Applier, Scissors, Hook-knife, and Suction/Irrigation Instrument). The FMX314 Instruments are locked into position in the instrument clamps of the FMX314 Introducer to activate a triangulated approach within the surgical field and facilitate independent anterior/posterior mobility. Each instrument is capable of 360 degree axial rotation of the end-effector as well as multidirectional lateral and superior/inferior mobility. The FMX314 Instruments and FMX314 Hub Cap & Sealing Unit are provided sterile and are single-use, disposable. When the surgical procedure is completed, the single-use FMX314 Instruments as well as the FMX314 Hub Cap & Sealing Unit are removed from the Introducer and discarded according to standard hospital protocol.

The Endo Keeper is intended to provide access for multiple instruments and/or endoscope to the abdominal cavity through a single incision during minimally invasive laparoscopic surgery. This device is single use and sterilized.

The Endo Keeper is intended to provide access for multiple instruments and/or endoscope to the abdominal cavity through a single incision during minimally invasive laparoscopic surgery. This device is single use and sterilized. The Endo Keeper is laparoscopic instrument port which retracts a small abdominal incision to allow multiple laparoscopic instruments to pass through to the abdomen. The Urethane Forming Sheet (components of the Endo Keeper) function is to cover the incision site of abdominal.

The QuadPort+ is intended for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery.

The ASC QuadPort+ Laparoscopic Access Devices are, like the parent TriPort+ device cleared by the FDA under K110004, laparoscopic multi-instrument ports which perform the following two functions. - Retracting a small abdominal incision to allow multiple laparoscopic instruments to pass . through to the abdomen at the same time during laparoscopic surgery. - Ensuring that pneumoperitoneum is maintained in the abdomen during the surgical procedure, whether or not one or more laparoscopic instruments are passing through the device. The QuadPort+ laparoscopic multi-instrument port is sterile and disposable. The QuadPort+ laparoscopic multi-instrument ports perform the same function as the TriPort+ parent device. Like the parent ASC TriPort+ Laparoscopic Access Device, the QuadPort+ laparoscopic multiinstrument port is comprised of the following three components: - An introducer component, which delivers the Distal Ring of the device through a pre-made . incision, into the abdominal cavity. - A retroctor component, which retracts an abdominal incision to allow the passage of ● laparoscopic instruments. - A valve component which maintains the pneumoperitoneum established for the surgical ● procedure. The QuadPort+ laparoscopic multi-instrument port is intended for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery. The QuadPort+ laparoscopic multi-instrument port functions in the same way as the ASC parent TriPort+ device cleared by the FDA under K110004.

The KeyPort AR System access device is an endoscopic accessory intended for use as a multiple instrument and/or camera port during minimally invasive anal-rectal procedures such as Transanal Endoscopic Microsurgery (no incision).

The KeyPort AR System is a reusable device used for creating and maintaining an artificial access port to body cavities including the necessary pneumoperitoneum. The KeyPort AR System allows multiple instruments and /or camera access during minimally invasive procedures, which include anal-rectal procedures such as Transanal Endoscopic Microsurgery (no incision). This product is exclusively intended for use by specialized medical personnel and must only be used by medically qualified and adequately trained persons. The KeyPort AR System is comprised of KeyPort silicone sealing insert (1), KeyPort AR trocar sleeve (2), and KeyPort trocar (3). The KeyPort AR System is used in conjunction with CO2 insufflator, Pump for smoke gas evacuation, and required instruments which are selected in accordance with the indications as well as the surgeon's requirements. Unless otherwise specified, all components of the KeyPort AR System are reusable and require sterilization before use. Methods of cleaning, disinfection, and sterilization are detailed in Instruction Manual GA-B 253-2 USA.

The ASC TriPort 15 Laparoscopic Access Device is intended for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery.

The ASC TriPort 15 Laparoscopic Access Device is a faparoscopic multi-instrument port which performs the following two functions: - Retracting a small abdominal incision to allow multiple laparoscopic instruments to pass . through to the abdomen at the same time during laparoscopic surgery. - Ensuring that pneumoperitoneum is maintained in the abdomen during the surgical . procedure, whether or not one or more laparoscopic instruments are passing through the device. The ASC TriPort 15 Laparoscopic Access Device is comprised of the following three components: - An introducer component, which delivers the Distal Ring through a pre-made incision, . into the abdominal cavity. - A refractor component, which retracts an abdominal incision to allow the passage of . laparoscopic instruments. - A valve component which maintains the pneumoperitoneum established for the surgical . procedure. The minor design changes to the cleared TriPort+ (K110004) device to create the TriPort 15 are as follows: - 1. Changing the valve configuration from a four valve (3 x 5mm & 1 x 10mm) to a three valve (2 x 5mm & 1 x 15mm) configuration. - 2. The introduction of a new colorant for the 15mm Valve Cap. Note that this portion of the device does not contact the patient. The changes made to the parent TriPort+ Laparoscopic Access Devices to produce the TriPort 15 are minor and do not represent changes to its intended use, or the operating principles or mechanism of action of the device. The ASC TriPort 15 Laparoscopic Access Device is sterile and disposable.

The OCTO™ Port is intended to use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery.

The OCTO™ Port is a sterile, disposable laparoscopic instrument port which retracts a small abdominal incision to allow multiple laparoscopic instruments to pass through to the abdomen.

The ASC TriPort+ Laparoscopic Access Device is intended for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery.

The ASC TriPort+ Laparoscopic Access Device is, like the parent TriPort and QuadPort devices cleared by the FDA under K101794, a laparoscopic multi-instrument port which performs the following two functions. - Retracting a small abdominal incision to allow multiple laparoscopic instruments to pass through to the abdomen at the same time during laparoscopic surgery. - Ensuring that pneumoperitoneum is maintained in the abdomen during the surgical procedure, whether or not one or more laparoscopic instruments are passing through the device. The ASC TriPort+ Laparoscopic Access Device is sterile and disposable. The proposed ASC TriPort+ Laparoscopic Access Device performs the same function as the TriPort and QuadPort parent devices. Like the parent ASC TriPort Laparoscopic Access Device, the proposed ASC TriPort+Laparoscopic Access Device is comprised of the following three components: - An introducer component, which delivers the Distal Ring of the ASC TriPort+ through a premade incision, into the abdominal cavity. - A retractor component, which retracts an abdominal incision to allow the passage of laparoscopic instruments. - A valve component which maintains the pneumoperitoneum established for the surgical procedure. The ASC TriPort+ Laparoscopic Access Device is intended for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery. The ASC TriPort+ Laparoscopic Access Device is identical in function to the ASC TriPort & QuadPort Laparoscopic Access Devices, which have been cleared for marketing under K101794.