FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

Lumendi Cleared for Endolumenal Interventional Platform

Nov. 14, 2018

The FDA granted 510(k) clearance for Lumendi’s endolumenal interventional platform used to improve tissue retraction during therapeutic endoscopies.

The device’s suture loops help to facilitate tissue manipulation and simplify dissection and removal of stomach polyps without surgical intervention.

The single-use, close-fitting non-sterile sleeve covers a standard endoscope to stabilize it inside the large intestine and can shift many gastrointestinal surgeries to endolumenal procedures.

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