FDA.report

510(k) K211607

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, S40 Sterilant Concentrate
Applicant
STERIS Corporation
510(k) number
K211607
Product code
MED
Decision
Substantially Equivalent (SESE)
Decision date
2021-09-07
Date received
2021-05-25
Regulation
880.6885
Classification name
Sterilant, Medical Devices
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
Jennifer Nalepka
Address
5960 Heisley Rd. Mentor OH US 44060 44060

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code MED

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K251666SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900STERIS Corporation2026-04-08
K232914SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900)STERIS Corporation2023-10-03
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K222615SYSTEM 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, S40 Sterilant ConcentrateSTERIS Corporation2022-09-28
K210737SYSTEM 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, S40 Sterilant ConcentrateSTERIS Corporation2021-05-12
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