510(k) K253693

Strut Suture; No-Tie Button by Riverpoint Medical, LLC — Product Code MBI

K253693 is an FDA 510(k) premarket notification submitted by Riverpoint Medical, LLC for the device "Strut Suture; No-Tie Button". The FDA issued a decision of Substantially Equivalent on March 11, 2026. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Riverpoint Medical, LLC has at least 10 other 510(k) clearances on record.