Remanufactured EndoWrist Cobra Grasper (420190)

The Remanufactured EndoWrist Cobra Grasper is a surgical instrument used with Intuitive Surgical's da Vinci robotic surgical systems (IS2000 and IS3000) for grasping and manipulating tissue during minimally invasive endoscopic procedures. It is used across multiple surgical specialties including urology, general laparoscopy, gynecology, otolaryngology, and cardiothoracic surgery, operated by trained physicians in operating room environments.

The remanufactured device has identical technological characteristics to the predicate OEM device, including the same design, materials, chemical composition, principle of operation, energy source, performance, and host system compatibility. The use counter has been reset to allow an additional controlled set of uses, but no modifications have been made to mechanical design, materials, or dimensions.

Testing included life cycle assessment per IEC 60601-1, biocompatibility testing per ISO 10993-1, electrical safety evaluation per IEC 60601-1, reprocessing validation per OEM instructions, and cybersecurity assessment per FDA Guidance on Cybersecurity in Medical Devices. The remanufactured EndoWrist ProGrasp Forceps (models 420093, K241872) was used as a reference for testing methods.

Substantial equivalence is established because the remanufactured device has identical intended use, technological characteristics, design, materials, and principle of operation to the predicate 420190 Cobra Grasper. A hazard assessment of the life extension and remanufacturing process identified no new risks, and testing confirmed performance and durability meet predicate specifications. The device resets the use counter to provide a controlled additional lifespan while maintaining all original safety and efficacy parameters.