Regulator
The FDA cleared Dexter for gallbladder removal through the 510(k) route.
A regulator's decision · Company-reported · Sets Dexter's stage
What the source says
“Distalmotion announced today that it received FDA 510(k) clearance for the use of its Dexter surgical robot in adult cholecystectomy (gallbladder removal).”
What it means
Dexter, from Distalmotion, is at stage 5 of 5 on our ladder: regulator-cleared or mass market. This event is one of the milestones that placed it there. This line rests on the company's own announcement; no regulator, customer or independent report confirms it in our sources yet.
Human help: Our sources report it working without human help.
More on Dexter
- The FDA cleared Dexter for more gynecology operations, including pelvic-organ prolapse repair and endometriosis surgery: its fourth US clearance.
- Distalmotion raised $150 million, led by Revival Healthcare Capital, to grow US sales. In January 2026 Johnson & Johnson's venture arm also invested an undisclosed amount.
- The FDA cleared Dexter for hysterectomy (removal of the womb) through the 510(k) route.
- AdventHealth, which runs 50 hospitals in nine states, bought several Dexter robots: the company's first multi-robot sale in the US.
- Surgeons at UC San Diego Health did the first two US outpatient operations with Dexter, both hernia repairs.
- The FDA cleared Dexter through the De Novo route (DEN230084) for groin (inguinal) hernia repair in adults. More than 1,300 patients had already been treated with it in Europe.