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Medical Devices / Submissions and Approvals

Ultrasonic System Gains 510(k) Clearance

Jan. 16, 2019

TransEnterix received FDA 510(k) clearance for its Senhance Ultrasonic System, a digital laparoscopic surgical platform.

The device is used for abdominal robotic surgery and allows surgeons to feel the forces the device’s instruments generate while working on delicate tissue.

The system offers reusable instruments with per-procedure costs similar to traditional laparoscopic surgeries and 3mm instruments for microlaparoscopic procedures that enable scarless incisions.

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