Remanufactured EndoWrist Tenaculum Forceps (420207)

The Remanufactured EndoWrist Tenaculum Forceps is a surgical instrument used with the da Vinci IS2000 and IS3000 robotic surgical systems for grasping and manipulating tissue during endoscopic procedures. The device is designed for use in urologic, general laparoscopic, gynecologic, otolaryngology, and thoracoscopic surgical procedures by trained physicians in operating room settings.

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 permit an additional controlled set of uses while maintaining all functional specifications.

Life testing for device performance and durability; electrical safety evaluation per IEC 60601-1; biocompatibility testing per ISO 10993-1; reprocessing validation per OEM instructions; and cybersecurity assessment per FDA Guidance on Cybersecurity in Medical Devices.

The remanufactured device is substantially equivalent because it has no modifications to mechanical design, materials, or dimensions compared to the predicate. Hazard assessment and risk analysis of the remanufacturing process were performed, with testing confirming that performance and durability are maintained through the life extension. Since indications for use, technological characteristics, and performance characteristics are identical to the predicate and no new safety or efficacy concerns were identified, substantial equivalence is demonstrated.