510(k) K123409

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

K123409 is an FDA 510(k) premarket notification submitted by Surgical Specialties Corp. Dba Angiotech for the device "QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN". The FDA issued a decision of Substantially Equivalent on November 20, 2012. The device falls under product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid), a Class II device regulated under 21 CFR 878.4493. Surgical Specialties Corp. Dba Angiotech has at least 6 other 510(k) clearances on record.