Therenva Sas: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Therenva Sas” (first 2014, latest 2022), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 62 days. Since 2017 the median was 93 days, against 123 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2014 | 1 | 57 |
| 2015 | 0 | — |
| 2016 | 1 | 62 |
| 2017 | 1 | 93 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 29 |
| 2022 | 1 | 103 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Therenva Sas took a median 93 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 123 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OWB | Interventional Fluoroscopic X-Ray System | 3 | 3 |
| LLZ | System, Image Processing, Radiological | 2 | 2 |
Review panels
- Radiology (5)
Most recent Therenva Sas 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K222070 | EndoNaut | OWB | 2022-10-25 | 103 |
| K212383 | EndoNaut | OWB | 2021-08-31 | 29 |
| K171829 | EndoNaut | OWB | 2017-09-21 | 93 |
| K160376 | EndoSize | LLZ | 2016-04-12 | 62 |
| K141475 | ENDOSIZE | LLZ | 2014-07-31 | 57 |
Recalls
openFDA lists no recalls under a recalling firm named Therenva Sas.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Therenva Sas?
FDA lists 5 510(k) clearances under the applicant name “Therenva Sas” (first 2014, latest 2022), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Therenva Sas?
The median time from FDA receipt to decision across 510(k)s cleared under the name Therenva Sas is 62 days. Since 2017: 93 days, versus 123 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Therenva Sas?
The most frequent FDA product codes under this applicant name are OWB (Interventional Fluoroscopic X-Ray System, 3); LLZ (System, Image Processing, Radiological, 2).
Next steps
- See all 5 Therenva Sas clearances with predicates and recalls
- Run predicate analysis for product code OWB, Therenva Sas's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.