Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Lumendi, LLC

FDA 510(k) & PMA Approved Devices — 8 products

Total Devices8
Categories2
Latest FDA decision2023-02-10
TypeNumberDevice NameCodeDateActions
510(k) K221452 DiLumen C1, EZ1 and Tool MountFDF2023-02-10 View
510(k) K211819 DiLumen C2 and Tool MountFDF2021-10-22 View
510(k) K210851 DiLumen Endolumenal Interventional Platform (DiLumen)FDF2021-04-21 View
510(k) K183112 DiLumen Endolumenal Interventional Knife (“DiLumen IK™”)GEI2019-08-02 View
510(k) K182540 DiLumen Endolumenal Interventional PlatformFDF2018-10-30 View
510(k) K173405 DiLumen Endolumenal Interventional Scissors (DiLumen Is)GEI2018-05-22 View
510(k) K173317 DiLumen C2; DiLumen Tool MountFDF2018-04-17 View
510(k) K162428 DiLumen Endolumenal Interventional PlatformFDF2016-12-06 View