510(k) K223476

V-PRO maX 2 Low Temperature Sterilization System by STERIS Corporation — Product Code MLR

K223476 is an FDA 510(k) premarket notification submitted by STERIS Corporation for the device "V-PRO maX 2 Low Temperature Sterilization System". The FDA issued a decision of Substantially Equivalent on August 7, 2023. The device falls under product code MLR (Sterilizer, Chemical), a Class II device regulated under 21 CFR 880.6860. STERIS Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 2023
Date Received
November 18, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilizer, Chemical
Device Class
Class II
Regulation Number
880.6860
Review Panel
HO
Submission Type