510(k) K242201

HyperSuture White/Green Extension Line by Threadstone, LLC — Product Code GAT

K242201 is an FDA 510(k) premarket notification submitted by Threadstone, LLC for the device "HyperSuture White/Green Extension Line". The FDA issued a decision of Substantially Equivalent on March 27, 2025. 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.