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FDA approves Intuitive Single-Site Instrumentation

The US Food and Drug Administration (FDA) has approved Intuitive Surgical's Single-Site Instrumentation for use with da Vinci Surgical System.

Single-Site Instrumentation is designed with a technology that enables laparoscopic cholecystectomy procedures via a single incision.

The Single-Site suite of instruments and accessories comprises a Single-Site Port, specialized curved cannulae and 5mm semi-rigid instruments, which are compatible with any da Vinci Si Surgical System.

The da Vinci Surgical System consists of a surgeon console or consoles, a patient-side cart with three or four interactive robotic arms, a vision system and proprietary EndoWrist instruments.

The da Vinci Surgical System provides surgeons with superior visualization, enhanced dexterity, greater precision and ergonomic comfort making it possible for more surgeons to perform minimally invasive procedures involving complex dissection or reconstruction.

Intuitive Surgical CEO Gary Guthart said they plan to initiate a controlled rollout of these products in the US, while continuing their rollout in Europe.

"As we learn more about our customers’ needs within single-incision surgery, we anticipate future submissions to the US FDA and other global regulatory agencies related to expansion of the cleared indications for use, as well as additional Single-Site instruments," Guthart said.