The following data is part of a premarket notification filed by Lumendi, Llc with the FDA for Dilumen Endolumenal Interventional Knife (“dilumen Ik™”).
| Device ID | K183112 |
| 510k Number | K183112 |
| Device Name: | DiLumen Endolumenal Interventional Knife (“DiLumen IK™”) |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| 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 | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-08 |
| Decision Date | 2019-08-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858836007058 | K183112 | 000 |
| 00858836007041 | K183112 | 000 |