510(k) K130078

QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN by Surgical Specialties Corp. Dba Angiotech — Product Code GAW

K130078 is an FDA 510(k) premarket notification submitted by Surgical Specialties Corp. Dba Angiotech for the device "QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN". The FDA issued a decision of Substantially Equivalent on February 28, 2013. The device falls under product code GAW (Suture, Nonabsorbable, Synthetic, Polypropylene), a Class II device regulated under 21 CFR 878.5010. Surgical Specialties Corp. Dba Angiotech has at least 6 other 510(k) clearances on record.