510(k) K014021

SHARPOINT COATED, FAST ABSORBING POLYGLYCOLIC ACID SYNTHETIC SUTURE, UNDYED by Surgical Specialties Corp — Product Code GAM

K014021 is an FDA 510(k) premarket notification submitted by Surgical Specialties Corp for the device "SHARPOINT COATED, FAST ABSORBING POLYGLYCOLIC ACID SYNTHETIC SUTURE, UNDYED". The FDA issued a decision of Substantially Equivalent on January 28, 2002. 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 has at least 10 other 510(k) clearances on record.