Search Results

The Applied Wound Protector/Retractor is indicated for use to: - Access the abdominal cavity during surgery through an atraumatically retracted incision. - Deliver maximum exposure of the abdominal cavity with minimum incision size. - Protect against wound contamination during laparoscopic and open surgery.

Applied Medical's Alexis O wound protector/retractors are disposable single-use surgical devices used to establish access to internal body cavities and spaces. The protector/retractors are designed for soft tissue retraction and provide 360 degrees of a circumferential retraction and 360 degrees of protection of the wound margins. The predicate Alexis devices are made in sizes ranging from Small to XLarge that accommodate incisions ranging from 2.5 to 17cm. This submission request clearance for adding an XXL and XXXL sizes to the product family. The XXL is for incisions ranging from 17 to 25cm; the XXXL is for incisions ranging from 25 to 30cm. The protector/retractors have a shelf life of three years and are delivered with a template that is used to determine the incision length for the corresponding retractor chosen for the procedure. Protector/retractors are packaged in a Tyvek pouch placed inside a carton.

The Alexis Orthopaedic Wound Retractor is indicated for use to access the musculoskeletal system through an atraumatically retracted wound

Wound retractors convert straight incisions into round openings that facilitate access to internal body cavities and spaces. APPLIED's wound retractors consist of a cylindrical flexible film sheath that has a semi-rigid polymer ring on each end. Retractors of this design are useful in open orthopaedic procedures that require unimpeded access while simultaneously protecting the wound.

The Alexis Laparoscopic System is indicated for use to: - Access the abdominal cavity during surgery through an atraumatically retracted incision. . - Deliver maximum exposure of the abdominal cavity with minimum incision size. . - Protect against wound contamination during laparoscopic and open surgery. . - Seal off the incision opening to permit insufflation of the peritoneum. Convert the . incision wound to an additional trocar port site. - Access the thoracic cavity or other soft tissue retraction during cardiac and general . surgical procedures through an atraumatically retracted incision.

Wound retractors convert straight incisions into semi round openings that facilitate access to internal body cavities and operative sites. These retractors are particularly useful in open or laparoscopic procedures that require removal of large quantities of tissue. The predicate and subject wound retractors share a common construction. Each consists of a flexible polymer membrane formed into the shape of a cylinder. Attached to each open end of the cylinder are two semi-rigid polymer rings. One ring (the inner ring) is positioned inside a body cavity while the other (outer ring) remains outside the patient. Rotating the outer ring inward - similar to rolling up a shirt sleeve - shortens the retractor and anchors the device in the patient. It also retracts the wound and converts the incision into a round opening. The flexible membrane that connects the rings protects the incised tissue throughout the procedure. The subject device has a snap-on silicone cap that closes and seals the wound opening. This allows the body cavity to be insufflated and the procedure to be completed under laparoscopic conditions. The center of the cap is designed to accommodate a 12mm trocar which effectively converts the wound retractor into a trocar port site.

The Alexis Wound Retractor (large and extra large size only) is indicated for use to provide abdominal access during routine non-urgent cesarean deliveries. The Alexis Wound Retractor was previously cleared for the following general indications for use (K041711) : - l Access the abdominal cavity during surgery through an atraumatically retracted incision. - 피 Delivery maximum exposure of the abdominal cavity with minimum incision size. - 트 Protect against wound contamination during laparoscopic and open surgery. - . Seal off the incision opening to permit insufflating the peritoneum. - 트 Convert the incision wound to an additional trocar port site. - 트 Access the thoracic cavity or other soft tissue retraction during cardiac and general surgical procedures through an atraumatically-retracted incision.

The Applied Wound Retractor consists of a flexible polymer membrane formed into the shape of a cylinder. Attached to each open end of the cylinder are two semi-rigid polymer rings. To perform these functions, Alexis Wound Retractors are constructed as a cylindrical membrane sheath that has two rings attached to each open end. The rings are molded in a plastic material The Wound Retractor package also includes an incision template. The Wound Retractor is simple to set up and easy to use. A sterile skin marker is used to mark an incision line at the surgery site and the incision is made. The Wound Protecting theath is placed in position through the incision with one ring inside the abdomen. The external ing is placed in traction and folded over itself until it contacts the abdomen. Once securely in place, the Alexis Wound Refractor keeps the incision open during the procedure. The wound protective sheath lines the incision and protects against wound contamination during the procedure. The Applied Wound Retractor is a disposable, single-use device and is packaged inside a Tyvek/Mylar peel pouch, which is standard packaging material for Applied's products. The packaged product is then placed in an outer product shelf pack.

The Applied Alexis Wound Retractor is indicated for use to: - Access the abdominal cavity during surgery through an atraumatically retracted incision. - Deliver maximum exposure of the abdominal cavity with minimum incision size. - Protect against wound contamination during laparoscopic and open surgery. The smaller two sizes of Alexis are also intended to be used to: - Seal off the incision opening to permit insufflating the peritoneum. - Convert the incision wound to an additional trocar port site. - Access the thoracic cavity or other soft tissue retraction during cardiac and general surgical through an atraumatically-retracted incision.

The Applied Wound Retractor consists of a flexible polymer membrane formed into the shape of a cylinder. Attached to each open end of the cylinder are two semi-rigid polymer rings. The device will be manufactured in five sizes, extra-small, small, medium, medium-large and large. The extra-small, small and medium products will have two additional indications. These models have an iris valve feature that allows the wound protector to be adjusted from fully open to fully closed. This capability allows Alexis to seal the incision area or to seal around a trocar. The procedure may then be returned to fully laparoscopic and an additional trocar may be placed through the incision site. The Wound Retractor package also includes an incision template. The Applied Wound Retractor is a disposable, single-use device and is packaged inside a Tyvek/Mylar peel pouch.