510(k) K113800

QUILL QUADRAHELIX TISSUE-CLOSURE DEVICE by Angiotech — Product Code GAW

K113800 is an FDA 510(k) premarket notification submitted by Angiotech for the device "QUILL QUADRAHELIX TISSUE-CLOSURE DEVICE". The FDA issued a decision of Substantially Equivalent on January 20, 2012. The device falls under product code GAW (Suture, Nonabsorbable, Synthetic, Polypropylene), a Class II device regulated under 21 CFR 878.5010. Angiotech has at least 6 other 510(k) clearances on record.