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Medical Device

FDA Rejects TransEnterix’ 510(k) For Surgibot

This article was originally published in Clinica

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Executive Summary

The US FDA has notified TransEnterix that the SurgiBot single-port, robotically enhanced laparoscopic surgical platform does not meet the criteria for substantial equivalence, according to the company.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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