510(k) K250095

All-Suture Dual Anchor System by Suturetech, Inc. — Product Code MBI

K250095 is an FDA 510(k) premarket notification submitted by Suturetech, Inc. for the device "All-Suture Dual Anchor System". The FDA issued a decision of Substantially Equivalent on September 5, 2025. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040.