510(k) K251666

SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 by STERIS Corporation — Product Code MED

K251666 is an FDA 510(k) premarket notification submitted by STERIS Corporation for the device "SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900". The FDA issued a decision of Substantially Equivalent on April 8, 2026. 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
April 8, 2026
Date Received
May 30, 2025
Clearance Type
Traditional
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