510(k) DEN240066
- Device
- COAPTIUM Connect with TISSIUM LIGHT
- Applicant
- Tissium SA
- 510(k) number
- DEN240066
- Product code
- SFD
- Decision
- Unknown (DENG)
- Decision date
- 2025-06-17
- Date received
- 2024-11-21
- Regulation
- 882.5270
- Classification name
- In Situ Polymerizing Peripheral Nerve Repair Device
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Clara Defraye
- Address
- 74 Rue Du Faubourg Saint Antoine Paris FR 75012 75012
FDA Registration Numbers#
- 3010659146
- 3010383847
- 3015546200
- 3010178296
- 3002807295
- 3021453307
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code SFD#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251957 | Coaptium Connect with Tissium Light | Tissium SA | 2025-09-08 |