The FDA has granted 510(k) clearance to Intuitive Surgical's da Vinci 5 robotic system for the full spectrum of colorectal procedures, including right and left hemicolectomy, low anterior resection and abdominoperineal resection.
The FDA has issued 510(k) clearance for Intuitive Surgical's da Vinci 5 robotic surgical system for colorectal surgery indications, expanding the platform's approved uses to cover the full spectrum of minimally invasive colorectal procedures.
The da Vinci 5, launched in 2024, features 10,000x greater computational power than its predecessor, real-time force feedback, and an integrated fluorescence imaging system for intraoperative tissue perfusion assessment.
Cleared Colorectal Indications
- Right and left hemicolectomy
- Sigmoid resection
- Low anterior resection (including TME)
- Abdominoperineal resection
- Hartmann's procedure reversal
- Rectopexy
A 1,200-patient multicentre study demonstrated that da Vinci 5-assisted colorectal surgery achieved a 2.1% conversion to open rate vs. 8.4% for laparoscopic surgery, with 30-day anastomotic leak rates of 1.4% vs. 3.2%.
Intuitive Surgical currently has over 9,000 da Vinci systems installed globally across all generations.