510(k) K251957
- Device
- Coaptium Connect with Tissium Light
- Applicant
- Tissium SA
- 510(k) number
- K251957
- Product code
- SFD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-09-08
- Date received
- 2025-06-25
- Regulation
- 882.5270
- Classification name
- In Situ Polymerizing Peripheral Nerve Repair Device
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Bahija Ikched
- Address
- 74 Rue Du Faubourg Saint Antoine Paris FR 75012 75012
FDA Registration Numbers#
- 3010659146
- 3010383847
- 3015546200
- 3010178296
- 3002807295
- 3021453307
Source Documents#
Other 510(k) Records For Product Code SFD#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN240066 | COAPTIUM Connect with TISSIUM LIGHT | Tissium SA | 2025-06-17 |