Entuit Secure Gastrointestinal Suture Anchor Set, Entuit Secure Adjustable Gastrointestinal Suture Anchor Set

Entuit Secure Gastrointestinal Suture Anchor Set, Entuit Secure Adjustable Gastrointestinal Suture Anchor Set is an FDA 510(k)-cleared medical device (K152524) manufactured by Cook Incorporated. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 29, 2015. Regulation: 8.