Cousin Biotech Sas: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Cousin Biotech Sas” (first 2008, latest 2019), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 258 days. Since 2017 the median was 259 days, against 83 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 258 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 2 | 159 |
| 2019 | 1 | 259 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Cousin Biotech Sas took a median 259 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 83 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FTL | Mesh, Surgical, Polymeric | 3 | 3 |
| OWI | Bone Fixation Cerclage, Sublaminar | 2 | 2 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 1 | 1 |
Review panels
Most recent Cousin Biotech Sas 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K181086 | Cortical Fixation Systems | MBI | 2019-01-09 | 259 |
| K181799 | ResCUBE Ligament Fixation System | OWI | 2018-08-29 | 55 |
| K172206 | NAJA Ligament Correction System | OWI | 2018-04-10 | 263 |
| K133889 | PREMIUM | FTL | 2014-09-04 | 258 |
| K093196 | BIOMESH CA.B.S. 'AIR COMPOSITE, MODELS: CABST1R05T, CABSAIRC7, CABSAIRC09 | FTL | 2010-06-25 | 259 |
| K072962 | CABS'AIR | FTL | 2008-06-26 | 251 |
Recalls
openFDA lists no recalls under a recalling firm named Cousin Biotech 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Cousin Biotech (1 510(k)s)
- Cousin Biotech S.A.R.L (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Cousin Biotech Sas?
FDA lists 6 510(k) clearances under the applicant name “Cousin Biotech Sas” (first 2008, latest 2019), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Cousin Biotech Sas?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cousin Biotech Sas is 258 days. Since 2017: 259 days, versus 83 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Cousin Biotech Sas?
The most frequent FDA product codes under this applicant name are FTL (Mesh, Surgical, Polymeric, 3); OWI (Bone Fixation Cerclage, Sublaminar, 2); MBI (Fastener, Fixation, Nondegradable, Soft Tissue, 1).
Next steps
- See all 6 Cousin Biotech Sas clearances with predicates and recalls
- Run predicate analysis for product code FTL, Cousin Biotech 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.