510(k) K003017

GRAMSORB SYNTHETIC ABSORBABLE SUTURE by Gramsmed, LLC — Product Code GAM

K003017 is an FDA 510(k) premarket notification submitted by Gramsmed, LLC for the device "GRAMSORB SYNTHETIC ABSORBABLE SUTURE". The FDA issued a decision of Substantially Equivalent on March 13, 2001. The device falls under product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid), a Class II device regulated under 21 CFR 878.4493. Gramsmed, LLC has at least 6 other 510(k) clearances on record.