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Medical Devices / Submissions and Approvals

FDA Clears Lumendi’s Single-Use Endoscopic Electrosurgical Knife

Aug. 21, 2019

The FDA granted Lumendi 510(k) clearance for its DiLumen Ik endolumenal interventional knife, a disposable device designed for use in endoscopic surgery.

Thrown away after a single use, the knife is a monopolar electrosurgical device used for cutting, dissecting and cauterizing tissue in the digestive tract during endoscopic procedures.

The product is also able to administer a submucosal injection as tissue dissection is taking place, to create a fluid cushion.

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