Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Lumendi with 8 510(k) clearances. The most recent is a 510(k) clearance dated Feb 10, 2023: DiLumen C1, EZ1 and Tool Mount.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Feb 10, 2023 | DiLumen C1, EZ1 and Tool MountK221452 · FDF | 510(k) clearances |
| Oct 22, 2021 | DiLumen C2 and Tool MountK211819 · FDF | 510(k) clearances |
| Apr 21, 2021 | DiLumen Endolumenal Interventional Platform (DiLumen)K210851 · FDF | 510(k) clearances |
| Aug 2, 2019 | DiLumen Endolumenal Interventional Knife (“DiLumen IK™”)K183112 · GEI | 510(k) clearances |
| Oct 30, 2018 | DiLumen Endolumenal Interventional PlatformK182540 · FDF | 510(k) clearances |
| May 22, 2018 | DiLumen Endolumenal Interventional Scissors (DiLumen Is)K173405 · GEI | 510(k) clearances |
| Apr 17, 2018 | DiLumen C2; DiLumen Tool MountK173317 · FDF | 510(k) clearances |
| Dec 6, 2016 | DiLumen Endolumenal Interventional PlatformK162428 · FDF | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
