FDA clears Medrobotics Flex System for ENT procedures

Jul 17, 2015 · Regulatory · Medrobotics · Surgical

The U.S. Food and Drug Administration cleared the Medrobotics Flex System through the 510(k) pathway for ear, nose and throat use.

Medrobotics company media
Company media · Medrobotics

Evidence notes

  • FDA recorded the Flex System under 510(k) K150776 with a decision date of July 17, 2015.
  • The Class II system was found substantially equivalent for flexible nasopharyngoscope use and related accessories.
  • The clearance enabled U.S. marketing of the steerable robotic access system for transoral ENT procedures.

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.

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