510(k) K233552

IDEAL Ziploop by Riverpoint Medical — Product Code MBI

K233552 is an FDA 510(k) premarket notification submitted by Riverpoint Medical for the device "IDEAL Ziploop". The FDA issued a decision of Substantially Equivalent on November 30, 2023. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Riverpoint Medical has at least 10 other 510(k) clearances on record.