510(k) K230094

Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors by Responsive Arthroscopy, LLC — Product Code MBI

K230094 is an FDA 510(k) premarket notification submitted by Responsive Arthroscopy, LLC for the device "Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors". The FDA issued a decision of Substantially Equivalent on August 25, 2023. 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.