510(k) K180321

Aesculap Optilene Nonabsorbable Suture by Aesculap, Inc. — Product Code GAW

K180321 is an FDA 510(k) premarket notification submitted by Aesculap, Inc. for the device "Aesculap Optilene Nonabsorbable Suture". The FDA issued a decision of Substantially Equivalent on March 7, 2018. The device falls under product code GAW (Suture, Nonabsorbable, Synthetic, Polypropylene), a Class II device regulated under 21 CFR 878.5010. Aesculap, Inc. has at least 10 other 510(k) clearances on record.