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# FDA Delays Review of TransEnterix SurgiBot System
- URL: https://www.fdaweb.com/fda-delays-review-of-transenterix-surgibot-system/
- Published: 2016-03-25T12:00:00.000Z
- Updated: 2026-09-14T20:51:11.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5135187

> TransEnterix says FDA has extended its review of a 510(k) for the SurgiBot System, a robotic surgery device for use in laparoscopic procedures. The system allows multiple instruments to be introduced and deployed through a single incision. The device’s flexible instruments may be controlled directly by the surgeon from inside the sterile field, with robotic assistance, the company says.  
>  
> FDA recently told the company that it has not yet concluded its review. As a result, TransEnterix has updated its timing expectations and now expects to receive a decision by mid-April. “We have been engaged in constructive dialog with the FDA throughout the entire submission process,” it says.