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FDA 510(k)

SYSTEM 1E Liquid Chemical Sterilant Processing System

K-Number: K170956 · 2017-09-22

ApplicantSTERIS Corporation
Decision Date2017-09-22
Product CodeMED
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SYSTEM 1E Liquid Chemical Sterilant Processing System is a medical device manufactured by STERIS Corporation. It received FDA 510(k) clearance on 2017-09-22 under approval number K170956. 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 1E Liquid Chemical Sterilant Processing System is a medical device that received FDA 510(k) clearance on 2017-09-22. It is manufactured by STERIS Corporation. The 510(k) number is K170956.

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

SYSTEM 1E Liquid Chemical Sterilant Processing System received FDA 510(k) clearance on 2017-09-22, under approval number K170956.

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

SYSTEM 1E Liquid Chemical Sterilant Processing System is manufactured by STERIS Corporation.

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

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

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Related PubMed Literature

PMID: 29653650 Comparison of adverse event and device problem rates for transcatheter aortic valve replacement and Mitraclip procedures as reported by the Transcatheter Valve Therapy Registry and the Food and Drug Administration postmarket surveillance data. American heart journal (2018)

Other Devices by STERIS Corporation

K160912Sterilization Tray K161683SYSTEM 1E Liquid Chemical Sterilant Processing System K160908Vis-U-All Low Temperature Sterilization Pouch/Tubing K160433V-PRO® 1 Plus and V-PRO® maX Low Temperature K160485VERIFY VH2O2 Indicator Tape K152630VERIFY STEAM Integrating Indicator

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Related Devices (Code: MED)

K161683SYSTEM 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 K190104SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing SystemSteris Corporations

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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