Surgitools Pty , Ltd.

Surgitools Pty, Ltd. specializes in single-use devices primarily for gynecological procedures. Their portfolio includes uterine manipulators, such as the CerviGrip Uterine Manipulator, and colpotomy tubes, including the ColpoWave Colpotomizer and ColpoWave Balloon. Some devices combine these functions, like the ColpoWave Colpotomizer paired with the CerviGrip Uterine Manipulator, to provide integrated solutions for stabilization and access during procedures like hysteroscopy and colpotomy.

Surgitools Pty, Ltd. is based in the United States. Their devices are designed and marketed for use within the U.S. market, where regulatory oversight applies. The company’s focus aligns with FDA requirements for medical devices intended for domestic distribution.

Surgitools’ devices fall under Class II classification according to FDA regulations. This classification applies to devices that generally pose moderate risk and require special controls to ensure safety and effectiveness, such as pre-market notifications (510(k)) and compliance with specific labeling or manufacturing requirements. The company’s products are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases, reflecting their regulatory status.

Surgitools’ devices are included in the FDA’s 510(k) database and the FDA’s Unique Device Identifier (UDI) system. These registries track pre-market notifications and device identification to ensure transparency and compliance with U.S. regulatory requirements. Listing in these databases confirms the devices’ authorized status for commercial distribution in the U.S.

Surgitools offers combined systems, such as the ColpoWave Colpotomizer paired with the CerviGrip Uterine Manipulator, to streamline gynecological procedures. These integrated designs provide simultaneous stabilization of the cervix (via the manipulator) and controlled access to the uterine cavity (via the colpotomy tube), reducing the need for separate instruments and improving procedural efficiency. This approach aligns with clinical needs for precision and workflow optimization.