Restore Robotics wins FDA nod to remanufacture new da Vinci instruments

Restore Robotics announced new FDA 510(k) clearances for the remanufacturing of two Intuitive da Vinci Xi robotic surgical instruments.

Clearance expands the Henderson, Nevada–based company’s portfolio of cleared instruments for remanufacturing. It aims to provide hospitals and surgery centers with cost-effective, high-quality, sustainable alternatives to purchasing new robotic instruments from original equipment manufacturers.

Restore Robotics remanufactures robotic surgical instruments to enhance affordability and sustainability. Last year, the company announced the first-in-human use of a remanufactured Intuitive da Vinci Xi robotic instrument on a patient using the newest model robotic surgical system, the da Vinci 5. The company holds the only clearance from the FDA to remanufacture Xi robotic instruments.

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