510(k) K151165

Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture by Aesculap, Inc. — Product Code GAR

K151165 is an FDA 510(k) premarket notification submitted by Aesculap, Inc. for the device "Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture". The FDA issued a decision of Substantially Equivalent on February 17, 2016. The device falls under product code GAR (Suture, Nonabsorbable, Synthetic, Polyamide), a Class II device regulated under 21 CFR 878.5020. Aesculap, Inc. has at least 10 other 510(k) clearances on record.