510(k) K221474

PRIMUS Healthcare Sterilizer (Model PSS11-HC) by Primus Sterilizer Company, LLC — Product Code FLE

K221474 is an FDA 510(k) premarket notification submitted by Primus Sterilizer Company, LLC for the device "PRIMUS Healthcare Sterilizer (Model PSS11-HC)". The FDA issued a decision of Substantially Equivalent on February 10, 2023. The device falls under product code FLE (Sterilizer, Steam), a Class II device regulated under 21 CFR 880.6880. Primus Sterilizer Company, LLC has at least 3 other 510(k) clearances on record.