The following data is part of a premarket notification filed by Lumendi, Llc with the FDA for Dilumen Endolumenal Interventional Platform (dilumen).
| Device ID | K210851 |
| 510k Number | K210851 |
| Device Name: | DiLumen Endolumenal Interventional Platform (DiLumen) |
| Classification | Colonoscope And Accessories, Flexible/rigid |
| Applicant | Lumendi, LLC 253 Post Road West Westport, CT 06880 |
| Contact | Dennis Daniels |
| Correspondent | John J. Smith Hogan Lovells U.S. LLP 555 13th Street NW Washington, DC 20004 |
| Product Code | FDF |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-22 |
| Decision Date | 2021-04-21 |