510(k) K261484

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

K261484 is an FDA 510(k) premarket notification submitted by Tas Medical, Inc. for the device "Tissue Approximation System". The FDA issued a decision of Substantially Equivalent on June 3, 2026. 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.