Lumendi, LLC
Westport, CT, US
LUMENDI, LLC appears in FDA device records in Westport, CT. FDA records list 8 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 8 510(k) clearances for Lumendi, LLC between 2016 and 2023. The busiest year on record is 2018, with 3. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2016 | 1 |
| 2018 | 3 |
| 2019 | 1 |
| 2021 | 2 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K221452 | DiLumen C1, EZ1 and Tool Mount | FDF | Substantially Equivalent | |
| K211819 | DiLumen C2 and Tool Mount | FDF | Substantially Equivalent | |
| K210851 | DiLumen Endolumenal Interventional Platform (DiLumen) | FDF | Substantially Equivalent | |
| K183112 | DiLumen Endolumenal Interventional Knife (“DiLumen IK™”) | GEI | Substantially Equivalent | |
| K182540 | DiLumen Endolumenal Interventional Platform | FDF | Substantially Equivalent | |
| K173405 | DiLumen Endolumenal Interventional Scissors (DiLumen Is) | GEI | Substantially Equivalent | |
| K173317 | DiLumen C2; DiLumen Tool Mount | FDF | Substantially Equivalent | |
| K162428 | DiLumen Endolumenal Interventional Platform | FDF | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3013505983 | 3013505983 | LUMENDI, LLC | 253 Post Road W, Westport, CT 06880 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain