510(k) K120827

QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIXANONE) by Angiotech — Product Code NEW

K120827 is an FDA 510(k) premarket notification submitted by Angiotech for the device "QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIXANONE)". The FDA issued a decision of Substantially Equivalent on July 13, 2012. The device falls under product code NEW (Suture, Surgical, Absorbable, Polydioxanone), a Class II device regulated under 21 CFR 878.4840. Angiotech has at least 6 other 510(k) clearances on record.