510(k) K171039

Assut Filbloc Permanent Sutures by Assut Europe S.P.A. — Product Code GAW

K171039 is an FDA 510(k) premarket notification submitted by Assut Europe S.P.A. for the device "Assut Filbloc Permanent Sutures". The FDA issued a decision of Substantially Equivalent on August 29, 2017. The device falls under product code GAW (Suture, Nonabsorbable, Synthetic, Polypropylene), a Class II device regulated under 21 CFR 878.5010. Assut Europe S.P.A. has at least 2 other 510(k) clearances on record.