Regulator
The FDA cleared the Senhance robot through the 510(k) route. It already had a CE mark for sale in Europe.
A regulator's decision · Company-reported · Sets Senhance Surgical System's stage
What the source says
“The Senhance Surgical Robotic System has received FDA 510(k) clearance and has been granted a CE Mark.”
What it means
Senhance Surgical System, from Asensus Surgical (formerly TransEnterix), owned by Karl Storz, 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 Senhance Surgical System
- Karl Storz said it would start an orderly end of service for Senhance, stop work on the LUNA robot and retire the Asensus brand.
- A North Carolina layoff notice showed about 108 Asensus jobs being cut, with the layoffs taking effect on 1 March 2027.
- German endoscope maker Karl Storz completed its purchase of Asensus for 35 cents a share in cash.
- Asensus recalled Senhance because faults could make the robot move on its own. The FDA called it a Class I recall, the most serious kind. Five US devices were affected and no patient harm was reported.
- FDA Class I recall: malfunctions could cause unintended robot movement. Five US devices affected; no patient harm reported.
- Asensus showed LUNA, a planned next surgical system. It was still in development and had not been sent to the FDA.