The following data is part of a premarket notification filed by Therenva Sas with the FDA for Endonaut.
| Device ID | K171829 |
| 510k Number | K171829 |
| Device Name: | EndoNaut |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | Therenva SAS 4 Rue Jean Jaures Rennes, FR 35000 |
| Contact | Matthis Hamy |
| Correspondent | Matthis Hamy Therenva SAS 4 Rue Jean Jaures Rennes, FR 35000 |
| Product Code | OWB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-20 |
| Decision Date | 2017-09-21 |
| Summary: | summary |