510(k) K192929

SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 by STERIS Corporation — Product Code MED

K192929 is an FDA 510(k) premarket notification submitted by STERIS Corporation for the device "SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900". The FDA issued a decision of Substantially Equivalent on December 10, 2019. The device falls under product code MED (Sterilant, Medical Devices), a Class II device regulated under 21 CFR 880.6885. STERIS Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 2019
Date Received
October 17, 2019
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilant, Medical Devices
Device Class
Class II
Regulation Number
880.6885
Review Panel
HO
Submission Type