510(k) K192824

Parcus Knotless AP Suture Anchors by Parcus Medical, LLC — Product Code MAI

K192824 is an FDA 510(k) premarket notification submitted by Parcus Medical, LLC for the device "Parcus Knotless AP Suture Anchors". The FDA issued a decision of Substantially Equivalent on Nov 2, 2019. The device falls under product code MAI (Fastener, Fixation, Biodegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3030. Parcus Medical, LLC has at least 10 other 510(k) clearances on record.