FDA clears Flex Robotic System for gastroenterology and urology
The FDA cleared the Medrobotics Flex Robotic System under 510(k) K172036 for gastroenterology and urology use.
Evidence notes
- FDA recorded an August 3, 2017 decision for the Flex Robotic System.
- The device was classified as a flexible or rigid colonoscope and accessories under product code FDF.
- The clearance expanded the platform beyond its earlier ear, nose and throat regulatory pathway.
Company context
Medrobotics developed the Flex Robotic System, a steerable platform for accessing difficult anatomical locations in minimally invasive procedures. The system combines a flexible robotic scope, visualisation and compatible instruments for surgeon-controlled intervention.