HyperSuture White/Green Extension Line

HyperSuture White/Green Extension Line is an FDA 510(k)-cleared medical device (K242201) manufactured by Threadstone, LLC. 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 March 26, 2025. Regulation: 8.