510(k) K253010

Mini Superhawk Suture Anchor System by Responsive Arthroscopy, LLC — Product Code MBI

K253010 is an FDA 510(k) premarket notification submitted by Responsive Arthroscopy, LLC for the device "Mini Superhawk Suture Anchor System". The FDA issued a decision of Substantially Equivalent on October 14, 2025. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Responsive Arthroscopy, LLC has at least 10 other 510(k) clearances on record.