FDA clears stapler for use with da Vinci SP surgical system

Today, April 10, 2025, the FDA granted 510(k) clearance to the SureForm 45 stapler for use with the da Vinci SP surgical system in urologic, thoracic, and colorectal procedures, Intuitive Surgical announced in a news release.¹

This approval marks the first clearance of a stapler designed for single-port robotic surgery in the US.

The da Vinci SP surgical system was FDA cleared in April 2014.

“Being able to use a SureForm 45 stapler in single-port robotic surgery helps provide surgeons with more control of their procedures from the da Vinci surgeon console, without the need to rely on an assistant to fire a stapler. This kind of control can help save valuable operating time,” said Myriam Curet, MD, chief medical officer for Intuitive, in the news release.¹

According to the company, the fully-wristed stapler continuously monitors tissue compression before and during firing through the use of SmartFire technology. This technology is also utilized in the staplers for multiport procedures.

Intuitive noted, “This real-time optimization helps surgeons enhance staple line integrity and reduce the risk of tissue damage across varying thicknesses.”

The SureForm 45 stapler is designed for use in conjunction with Intuitive’s single-port surgical system, da Vinci SP, which is cleared in the US for urologic, transoral otolaryngology, colorectal, and thoracic procedures.

The device is equipped with 3 multi-jointed, wristed instruments and a high-definition, 3D camera. These instruments are triangulated to ensure that there are no external instrument collisions during the procedure.

The system was initially cleared for urological surgical procedures appropriate for a single-port approach in April 2014.² The indications for the surgical platform were expanded in 2023 when the FDA issued clearance of the device for simple prostatectomy, as well as for transvesical approach to simple and radical prostatectomy.³

The da Vinci SP surgical systemalso has approval across a variety of surgical procedures in Europe, Japan, Korea, and Taiwan.

Intuitive’s portfolio of robotic platforms also includes a suite of multiport systems, which include the da Vinci 5, Xi, and X. The most recent generation of their multiport system, the da Vinci 5, was granted FDA clearance last year, in March 2024.⁴

REFERENCES

1. U.S. FDA clears first stapler designed for single-port robotic surgery. News release. Intuitive Surgical. Published online and accessed April 10, 2025. https://isrg.intuitive.com/news-releases/news-release-details/us-fda-clears-first-stapler-designed-single-port-robotic-surgery

2. Intuitive Surgical announces FDA clearance of da Vinci(R) Sp(TM) surgical system. News release. Intuitive Surgical. April 22, 2014. Accessed April 10, 2025. https://isrg.intuitive.com/news-releases/news-release-details/intuitive-surgical-announces-fda-clearance-da-vincir-sptm

3. Intuitive receives FDA clearance of da Vinci SP for simple prostatectomy. News release. Intuitive Surgical. April 28, 2023. Accessed April 10, 2025. https://investor.intuitivesurgical.com/news-releases/news-release-details/intuitive-receives-fda-clearance-da-vinci-sp-simple/

4. Intuitive announces FDA clearance of fifth-generation robotic system, da Vinci 5. News release. Intuitive Surgical. March 14, 2024. Accessed April 10, 2025. https://isrg.intuitive.com/news-releases/news-release-details/intuitive-announces-fda-clearance-fifth-generation-robotic