510(k) K192964

Parcus Synd-EZ SS by Parcus Medical, LLC — Product Code MBI

K192964 is an FDA 510(k) premarket notification submitted by Parcus Medical, LLC for the device "Parcus Synd-EZ SS". The FDA issued a decision of Substantially Equivalent on Nov 22, 2019. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Parcus Medical, LLC has at least 10 other 510(k) clearances on record.