Taurus Clip

The Taurus Clip is a sterile, single-use endoscopic clip designed for closure, hemostasis, endoscopic marking, and anchoring within the gastrointestinal tract of adult patients. It consists of a preloaded titanium clip implant and a flexible delivery system (Applier) compatible with endoscopes having working channels of 2.8mm or greater.

The Taurus Clip has identical intended use, indications for use, working length, principle of operation, patient population, and system configuration as the predicate Resolution Clip Platform (K222503). It differs in clip geometry and tooth length compared to the predicate, though the subject device's tooth length is shorter than the reference device Padlock Clip (K192722). Both subject and predicate devices are single-use, sterilized with ethylene oxide.

ISO 10993-1 Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing; ISO 11135-1 Sterilization of Health Care Products – Ethylene Oxide – Part 1: Requirements for Development, Validation, and Routing Control of Sterilization Process for Medical Devices; ISO 10993-7 Biological Evaluation of Medical Devices – Part 7: Ethylene Oxide Sterilization Residuals.

The Taurus Clip is substantially equivalent to the Resolution Clip Platform (K222503) because the technological differences in clip geometry do not raise new or different questions of safety and effectiveness. Non-clinical performance data and testing demonstrate the device meets predetermined acceptance criteria comparable to the legally marketed predicate device.