Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter)

Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter) is an FDA 510(k)-cleared medical device (K160754) manufactured by Venclose, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 8, 2016. Regulation: 8.