ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler

ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler is an FDA 510(k)-cleared medical device (K160969) manufactured by Shinemed, 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 December 11, 2016. Regulation: 8.