FDA.report

510(k) K223476

Device
V-PRO maX 2 Low Temperature Sterilization System
Applicant
STERIS Corporation
510(k) number
K223476
Product code
MLR
Decision
Substantially Equivalent (SESE)
Decision date
2023-08-07
Date received
2022-11-18
Regulation
880.6860
Classification name
Sterilizer, Chemical
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Anthony Piotrkowski
Address
5960 Heisley Rd. Mentor OH US 44060 44060

FDA Registration Numbers

Source Documents

510(k) summary PDF

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K222093V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization SystemSteris2022-09-09
K220404STERRAD NX with ALLClear TechnologyAdvanced Sterilization Products, Inc.2022-05-16
K212200STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM CassettePlasmapp Co,., Ltd.2021-10-22
K212174STERRAD 100NX Sterilizer with ALLClear TechnologyAdvanced Sterilization Products, Inc.2021-10-09
K190005Sterilucent HC 80TT Hydrogen Peroxide SterilizerSterilucent, Inc.2019-09-13
K190917V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature Sterilization SystemsSTERIS Corporation2019-05-09