The following data is part of a premarket notification filed by Crospon Ltd with the FDA for Endoflip System.
| Device ID | K183072 |
| 510k Number | K183072 |
| Device Name: | EndoFLIP System |
| Classification | System, Gastrointestinal Motility (electrical) |
| Applicant | Crospon Ltd Galway Business Park, Dangan Galway, IE |
| Contact | John O'dea |
| Correspondent | Avishag Metzer Medtronic 2 Hacarmet St. New Industrial Park POB 258 Yoqneam, IL 20962 |
| Product Code | FFX |
| CFR Regulation Number | 876.1725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-05 |
| Decision Date | 2019-02-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521809427 | K183072 | 000 |
| 20884521809410 | K183072 | 000 |
| 10884521809376 | K183072 | 000 |
| 10884521809321 | K183072 | 000 |
| 10884521809314 | K183072 | 000 |
| 10884521809307 | K183072 | 000 |
| 10884521808096 | K183072 | 000 |
| 10884521826823 | K183072 | 000 |