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Medical Devices / Submissions and Approvals

FDA Clears Disposable Sheath for Hysteroscopy System

Nov. 11, 2019

UVision360 has received 510(k) clearance for a rotatable disposable sheath attachment for its Luminelle DTx hysteroscopy system.

The system uses a wide-angle lens, long depth of view and an algorithm that automatically adjusts focus and lighting during hysteroscopy and cystoscopy procedures.

The newly cleared attachment measures 3mm in diameter, reducing the need for anesthesia due to its small size, the company said.

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