Authorization covers multiple procedures across general surgery, including Roux-en-Y gastric bypass, gastrectomy, cholecystectomy, splenectomy, gastric sleeve, small bowel resection, appendectomy, lysis of adhesions, fundoplication, and hiatal hernia repair.

J&J submitted the robot to the FDA for de novo approval in January. In May, the company said Ottava met its endpoints in a pivotal study.

The FDA’s green light marks a significant milestone for Johnson & Johnson and Ottava, nearly six years after first unveiling the soft-tissue platform that it hopes will challenge longtime leader Intuitive Surgical’s da Vinci system. It also marks the second major surgical robot approval within the last year, as Medtronic’s Hugo also got an FDA nod for urologic procedures in late 2025.