510(k) K173493

Amsco Evolution Floorloader Steam Sterilizer HC-2000 and HC-3000 by STERIS Corporation — Product Code FLE

K173493 is an FDA 510(k) premarket notification submitted by STERIS Corporation for the device "Amsco Evolution Floorloader Steam Sterilizer HC-2000 and HC-3000". The FDA issued a decision of Substantially Equivalent on Feb 23, 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.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Feb 23, 2018
Date Received
Nov 13, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilizer, Steam
Device Class
Class II
Regulation Number
880.6880
Review Panel
HO
Submission Type
510(k)