Data / Medical devices / France / Therenva
Therenva: FDA-registered device maker in Rennes Bretagne, France, 3 510(k) clearances
Therenva is registered with the FDA (registration 3011240766) in Rennes Bretagne, France. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated October 25, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011240766
- Address
- 74 F rue de Paris, Rennes Bretagne, France, 35000
- Owner or operator
- Therenva (10047554)
- Roles
- Manufacturer
- First device listed
- October 6, 2014
- Registered through
- 2026
- Brand names listed
- EndoNaut, EndoSize
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Interventional Fluoroscopic X-Ray System | OWB | 2 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| October 25, 2022 | K222070 | EndoNaut | OWB | Substantially Equivalent | Therenva Sas | accessdata.fda.gov |
| April 12, 2016 | K160376 | EndoSize | LLZ | Substantially Equivalent | Therenva Sas | accessdata.fda.gov |
| July 31, 2014 | K141475 | ENDOSIZE | LLZ | Substantially Equivalent | Therenva Sas | accessdata.fda.gov |
Compare with other makers
- All makers of System, Image Processing, Radiological
- All makers of Interventional Fluoroscopic X-Ray System
Updated October 25, 2022. 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.