SUTURE WELDING SYSTEM AND KIT (SWK)

SUTURE WELDING SYSTEM AND KIT (SWK) is an FDA 510(k)-cleared medical device (K983108) manufactured by Axya Medical, 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 November 26, 1998. Regulation: 8.