Remanufactured EndoWrist Cadiere Forceps (420049)

The Remanufactured EndoWrist Cadiere Forceps is a grasping and manipulation instrument used with da Vinci S and Si Surgical Systems for endoscopic procedures. It is used across multiple surgical specialties including urology, general laparoscopy, gynecology, otolaryngology, and thoracoscopy, with applications in urologic, general laparoscopic, gynecologic laparoscopic, transoral otolaryngology, general thoracoscopic, and thoracoscopically assisted cardiotomy procedures.

The remanufactured Cadiere Forceps maintains identical design, materials, chemical composition, principle of operation, energy source, performance, and host system compatibility as the predicate OEM device. The use counter has been reset to allow for an additional controlled set of uses. No modifications have been made to mechanical design, materials, or dimensions.

Testing included life testing (per IEC 60601-1), biocompatibility testing (per ISO 10993-1), electrical safety evaluation, reprocessing validation per OEM instructions, and cybersecurity assessment per FDA Guidance on Cybersecurity in Medical Devices.

Substantial equivalence is based on identical indications for use, identical technological characteristics with no design or material changes, and demonstrated equivalent performance through comparative testing. The remanufactured device undergoes the same safety and performance assessments as the predicate without raising any new questions of safety or efficacy, as confirmed by the detailed comparison of intended use and technological characteristics.