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FDA 510(k)

SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System

K-Number: K190104 · 2019-03-22

ApplicantSteris Corporations
Decision Date2019-03-22
Product CodeMED
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System is a medical device manufactured by Steris Corporations. It received FDA 510(k) clearance on 2019-03-22 under approval number K190104. The device is classified under product code MED. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System?

SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System is a medical device that received FDA 510(k) clearance on 2019-03-22. It is manufactured by Steris Corporations. The 510(k) number is K190104.

When was SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System approved by the FDA?

SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System received FDA 510(k) clearance on 2019-03-22, under approval number K190104.

What company makes SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System?

SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System is manufactured by Steris Corporations.

What is the FDA product code for SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System?

The FDA product code for SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System is MED.

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Related PubMed Literature

PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026) PMID: 40942190 Recent Progress in Cellulose Nanofibril Hydrogels for Biomedical Applications. Polymers (2025)

Other Devices by Steris Corporations

K182931VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag K180342SYSTEM 1E Liquid Chemical Sterilant Processing System K172748VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack K183295Celerity HP Chemical Indicator (CI) K183300VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack K203630BioGuard Air/Water and Suction Valves

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Related Devices (Code: MED)

K161683SYSTEM 1E Liquid Chemical Sterilant Processing SystemSTERIS Corporation K170956SYSTEM 1E Liquid Chemical Sterilant Processing SystemSTERIS Corporation K180342SYSTEM 1E Liquid Chemical Sterilant Processing SystemSteris Corporations K173256System 1 endo Liquid Chemical Sterilant Processing SystemSTERIS Corporation K192929SYSTEM 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 P6900STERIS Corporation K191343SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900STERIS Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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