Tissium SA: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Tissium SA” (first 2025, latest 2025), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time under this name: 75 days. 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 |
|---|---|---|
| 2025 | 1 | 75 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Tissium SA took a median 75 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 75 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| SFD | In Situ Polymerizing Peripheral Nerve Repair Device | 2 | 1 |
Review panels
- Neurology (2)
Most recent Tissium SA 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251957 | Coaptium Connect with Tissium Light | SFD | 2025-09-08 | 75 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN240066 | De Novo | In Situ Polymerizing Peripheral Nerve Repair Device | 2025-06-17 |
Recalls
8 product recalls in 1 recall events; 8 initiated in the last five years. Most recent: 2026-06-15.
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 Tissium SA?
FDA lists 1 510(k) clearance under the applicant name “Tissium SA” (first 2025, latest 2025), plus 1 De Novo decision, across 1 product code 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 Tissium SA?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tissium SA is 75 days.
Which FDA product codes appear under Tissium SA?
The most frequent FDA product codes under this applicant name are SFD (In Situ Polymerizing Peripheral Nerve Repair Device, 2).
Next steps
- See all 1 Tissium SA clearances with predicates and recalls
- Run predicate analysis for product code SFD, Tissium SA'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.