8mm Monopolar Curved Scissors (470179)

The 8mm Monopolar Curved Scissors (470179) is a reusable surgical instrument designed for use with da Vinci robotic surgical systems (Xi and X models). It is used for endoscopic tissue manipulation including cutting, blunt and sharp dissection, and electrocautery during various surgical procedures including urologic, general laparoscopic, gynecologic, and thoracoscopic operations.

The remanufactured device maintains identical mechanical design, materials, and size to the predicate device after ten reuse cycles. The instrument consists of housing, shaft, wrist, and tip components with a single-use cover accessory. The EndoWrist design provides natural dexterity and greater range of motion than the human hand for minimally invasive procedures.

Not stated in this summary.

Substantial equivalence is based on identical intended use, technological characteristics, and performance data. After ten additional reuse cycles through remanufacturing, the subject device is mechanistically and functionally equivalent to the predicate in form, fit, and function with no changes to claims, intended use, clinical applications, or method of operation. Design verification and validation testing including biocompatibility, functional performance, bioburden cleaning, bacterial endotoxins, and electrical safety demonstrated the remanufactured device operates as safely and effectively as the predicate.