Performance Tests – Bench, Animal, Clinical
Most 510(k) submissions will include some type of performance data. The extent of performance data w...
FDA 510k Biocompatibility Assessment
* In general, clinical studies will not be needed for most surgical suture devices, FDA may recommen...
Surgical Sutures 510(k)
* In general, clinical studies will not be needed for most surgical suture devices, FDA may recommen...