Data / Medical devices / United States / Lumendi, LLC
Lumendi, LLC: FDA-registered device maker in Westport, CT, United States, 4 510(k) clearances
Lumendi, LLC is registered with the FDA (registration 3013505983) in Westport, CT, United States. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated February 10, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013505983
- Address
- 253 Post Road W, Westport, CT, United States, 06880
- Owner or operator
- Lumendi, LLC (10054295)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- March 5, 2017
- Registered through
- 2026
- Brand names listed
- DiLumen C1 EZ1, DiLumen EZ Glide, DiLumen Endolumenal Interventional Platform, DiLumen Endolumenal Interventional Platform D-1000, DiLumen Endolumenal Interventional Platform D-1001, DiLumen Endolumenal Interventional Platform D-1002, DiLumen Ig, Endolumenal Interventional Grasper
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Colonoscope And Accessories, Flexible/Rigid | FDF | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt | PTS | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 10, 2023 | K221452 | DiLumen C1, EZ1 and Tool Mount | FDF | Substantially Equivalent | Lumendi, LLC | accessdata.fda.gov |
| April 21, 2021 | K210851 | DiLumen Endolumenal Interventional Platform (DiLumen) | FDF | Substantially Equivalent | Lumendi, LLC | accessdata.fda.gov |
| October 30, 2018 | K182540 | DiLumen Endolumenal Interventional Platform | FDF | Substantially Equivalent | Lumendi, LLC | accessdata.fda.gov |
| December 6, 2016 | K162428 | DiLumen Endolumenal Interventional Platform | FDF | Substantially Equivalent | Lumendi, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Colonoscope And Accessories, Flexible/Rigid
- All makers of Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt
Updated February 10, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.