510(k) K234079

HyperSuture Extension Line by Threadstone, LLC — Product Code GAT

K234079 is an FDA 510(k) premarket notification submitted by Threadstone, LLC for the device "HyperSuture Extension Line". The FDA issued a decision of Substantially Equivalent on May 10, 2024. The device falls under product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene), a Class II device regulated under 21 CFR 878.5000. Threadstone, LLC has at least 4 other 510(k) clearances on record.