Uterine manipulator, single-use

A uterine manipulator, single-use is a sterile, hand-held surgical instrument used to gently move and position the uterus during gynecological procedures such as laparoscopy. It helps improve visibility of pelvic anatomy and allows for procedures like chromotubation by using an inflatable balloon placed transcervically into the uterus, which is then manipulated via a connected syringe.

This category includes only single-use devices that are supplied sterile and intended for one procedure before disposal. As manual instruments without electronic components or drug coatings, they are regulated based on their mechanical function and patient contact duration, with regulatory status determined by individual device assessment in each jurisdiction.