EndoRobotics receives FDA 510(k) clearance for ROBOPERA

Date: 2025-09-24 · Type: regulatory · Company: EndoRobotics

The FDA granted 510(k) clearance for EndoRobotics' ROBOPERA ER-R-002 and ER-R-003 devices.

The FDA granted 510(k) clearance for EndoRobotics' ROBOPERA ER-R-002 and ER-R-003 devices.
FDA records list the decision date as September 24, 2025 and classify the device under gastroenterology/urology with product codes FDF, FDS and NAY.
The FDA summary describes ROBOPERA as a system intended to hold and lift tissue and mucosal membrane in the esophagus, stomach, colon and rectum during endoscopic surgical procedures.