LS-5 ePTFE Suture

LS-5 ePTFE Suture is an FDA 510(k)-cleared medical device (K163639) manufactured by Lsi Solutions. 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 June 1, 2017. Regulation: 8.