QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIOXANONE)

QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIOXANONE) is an FDA 510(k)-cleared medical device (K113744) manufactured by Angiotech. 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 January 31, 2012. Regulation: 8.