510(k) for Vidamed electrosurgical system:
This article was originally published in Clinica
Vidamed (US) has received 510(k) clearance from the FDA for an electrosurgical system for use in the coagulation and desiccation of tissue. The Menlo Park (California)-based company expects the system to be introduced in the first half of 1996 as its first product in the US. The clearance is for general surgical use; Vidamed is prohibited from marketing it for more specific indications without additional FDA clearances, which may require the submission of clinical data.