Endo Tools Therapeutics

Endo Tools Therapeutics specializes in single-use medical devices for minimally invasive surgery. Their primary products include endoscopic overtubes and suturing units, such as the endomina system and TAPES, which are part of the endomina platform. These devices are designed to assist in precise tissue manipulation and closure during endoscopic procedures.

Endo Tools Therapeutics is based in the United States. As a manufacturer, they develop devices in compliance with U.S. regulatory requirements, including those governing medical device classification, labeling, and post-market surveillance. Their products are subject to FDA oversight, ensuring they meet safety and performance standards for their intended use.

Endo Tools Therapeutics’ devices, including endoscopic overtubes and suturing units, fall under Class II classification by the FDA. This classification applies to devices that pose moderate risk and require special controls beyond general controls to ensure their safety and effectiveness. The classification ensures these devices undergo rigorous evaluation before authorization.

Yes, Endo Tools Therapeutics’ devices are included in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their lifecycle, ensuring transparency in regulatory reporting, post-market surveillance, and patient safety monitoring. Listing in this database is a requirement for Class II devices in the U.S.