Company · US
Lumendi, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2016 to 2023. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 10, 2023 | K221452 | DiLumen C1, EZ1 and Tool Mount Lumendi, LLC | FDF |
| Oct 22, 2021 | K211819 | DiLumen C2 and Tool Mount Lumendi, LLC | FDF |
| Apr 21, 2021 | K210851 | DiLumen Endolumenal Interventional Platform (DiLumen) Lumendi, LLC | FDF |
| Aug 2, 2019 | K183112 | DiLumen Endolumenal Interventional Knife (DiLumen IK) Lumendi, LLC | GEI |
| Oct 30, 2018 | K182540 | DiLumen Endolumenal Interventional Platform Lumendi, LLC | FDF |
| May 22, 2018 | K173405 | DiLumen Endolumenal Interventional Scissors (DiLumen Is) Lumendi, LLC | GEI |
| Apr 17, 2018 | K173317 | DiLumen C2; DiLumen Tool Mount Lumendi, LLC | FDF |
| Dec 6, 2016 | K162428 | DiLumen Endolumenal Interventional Platform Lumendi, LLC | FDF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||