Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184)

The Robotic Surgical Instruments—Permanent Cautery Hook (470183) and Permanent Cautery Spatula (470184)—are reusable, non-sterile instruments designed for use with the da Vinci X/Xi Surgical System by Intuitive Surgical. They enable precise dissection and division of tissue using monopolar cautery in minimally invasive surgical procedures including urologic, general laparoscopic, gynecologic, and thoracoscopic surgeries.

The subject devices are identical in design, materials, dimensions, and functional characteristics to the predicate device (da Vinci X Surgical System, K131861). Each instrument consists of housing, shaft, wrist, and tip components enabling multiple axes of articulation. The remanufactured instruments are restored to original form, fit, and function through validated inspection, repair, testing, and cleaning procedures with no new technological characteristics introduced.

ISO 10993 (Biocompatibility), IEC 60601-1 (Electrical Safety), ISO 13485 (Design Controls, Nonconforming Product, Corrective and Preventative Actions), cleaning validation including protein, hemoglobin, and TOC residue analysis, and functional performance testing (mechanical and electrical).

The subject devices have identical intended use and technological characteristics to the predicate device and introduce no new clinical applications, anatomical targets, or surgical modalities. Comprehensive design verification, cleaning validation, and functional testing confirm the remanufactured instruments meet all applicable design requirements and perform equivalently to the predicate device, raising no new questions of safety or effectiveness.