ProCinch Adjustable Loop Device

ProCinch Adjustable Loop Device is an FDA 510(k)-cleared medical device (K150416) manufactured by Stryker Endoscopy. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 16, 2015. Regulation: 8.