510(k) K151112

Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop Design by Angiotech — Product Code GAW

K151112 is an FDA 510(k) premarket notification submitted by Angiotech for the device "Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop Design". The FDA issued a decision of Substantially Equivalent on September 10, 2015. 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.