EndoRobotics receives FDA 510(k) clearance for ROBOPERA
Evidence notes
- 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.
Company context
EndoRobotics develops robot-assisted endoscopic intervention technologies for gastrointestinal procedures. Its portfolio includes systems and tools for flexible endoscopic robotic control and precise therapy inside the digestive tract.