
Lumendi, LLC
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DiLumen Endolumenal Interventional Platform is an FDA 510(k)-cleared medical device (K182540) manufactured by Lumendi, LLC. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 29, 2018. Regulation: 8.