510(k) K173490

Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000) by STERIS Corporation — Product Code FLE

K173490 is an FDA 510(k) premarket notification submitted by STERIS Corporation for the device "Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000)". The FDA issued a decision of Substantially Equivalent on Feb 22, 2018. The device falls under product code FLE (Sterilizer, Steam), a Class II device regulated under 21 CFR 880.6880. STERIS Corporation has 204 other 510(k) clearances on record.