Intuitive has obtained U.S. Food and Drug Administration (FDA) clearance of its da Vinci Single Port (SP) surgical system for transanal local excision/resection.

This is a form of minimally invasive surgery done through a natural orifice to avoid abdominal surgical incisions for some procedures. This clearance broadens da Vinci SP’s capabilities in colorectal surgery, building on procedures previously cleared by the FDA in November 2024, which include transabdominal procedures—low anterior resection, total mesorectal excision, colectomy, abdominoperineal resection, and sigmoidectomy.

The surgical robot was engineered to navigate in narrow body cavities needing precise access, like lower pelvis and rectal procedures. Its design and architecture support rectal anatomy access with control of up to three multi-jointed instruments and a high-def, articulating camera through a single entry point to freely work in the smaller space.

The robot also helps mitigate challenges inherent with laparoscopic transanal minimally invasive surgery, such as surgeon ergonomics, reaching lesions in the upper rectum, and working circumferentially, or “upside-down,” when needed. Surgeons can dissect, suture, and excise through a natural orifice, avoiding external scarring for patients, unlike conventional transabdominal rectal resection, which typically needs multiple incisions and removal of the rectum.

The FDA has previously cleared it for certain urology procedures, including simple prostatectomy, as well as transoral otolaryngology and general thoracoscopic procedures. da Vinci SP is also approved for use in Europe, Japan, and Korea for a range of procedures spanning multiple surgical disciplines.

“Using the da Vinci SP will help me adapt some of my transabdominal low anterior resections to transanal surgeries for appropriate lesions,” said Laila Rashidi, M.D., of MultiCare Tacoma General Hospital in Tacoma, Wash.

“With FDA’s clearance of the da Vinci SP system for transanal local resection, surgeons have a new option in colorectal surgery to positively impact patient outcomes,” said Intuitive executive VP and chief medical officer Myriam Curet, MD. “Da Vinci SP represents a major leap forward for minimally invasive colorectal surgery, supporting surgeons in better preserving healthy tissue and accelerating patient recovery.”

Last month, the company won an FDA nod for its fully wristed SP (single-port) SureForm 25 stapler for use with da Vinci SP in thoracic, colorectal, and urologic procedures.