IMPLICITGUIDE SURGICAL SUTURE SYSTEM

IMPLICITGUIDE SURGICAL SUTURE SYSTEM is an FDA 510(k)-cleared medical device (K091061) manufactured by Implicitcare, 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 November 12, 2009. Regulation: 8.