K251957
- 510(k) number
- K251957
- Device name
- Coaptium Connect with Tissium Light
- Applicant
- Tissium SA FR
- Product code
- SFD — In Situ Polymerizing Peripheral Nerve Repair Device
- Decision date
- 2025-09-08
- Date received
- 2025-06-25
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K251957.pdf
Official FDA record: K251957
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.