510(k) K220980

Tissue Approximation System (TAS) by Tas Medical, Inc. — Product Code GAR

K220980 is an FDA 510(k) premarket notification submitted by Tas Medical, Inc. for the device "Tissue Approximation System (TAS)". The FDA issued a decision of Substantially Equivalent on July 5, 2023. The device falls under product code GAR (Suture, Nonabsorbable, Synthetic, Polyamide), a Class II device regulated under 21 CFR 878.5020. Tas Medical, Inc. has at least 1 other 510(k) clearance on record.