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FDA 510(k)

enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System

K-Number: K243433 · 2024-12-02

ApplicantSTERIS Corporation
Decision Date2024-12-02
Product CodeFEB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System is a medical device manufactured by STERIS Corporation. It received FDA 510(k) clearance on 2024-12-02 under approval number K243433. The device is classified under product code FEB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System?

enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System is a medical device that received FDA 510(k) clearance on 2024-12-02. It is manufactured by STERIS Corporation. The 510(k) number is K243433.

When was enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System approved by the FDA?

enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System received FDA 510(k) clearance on 2024-12-02, under approval number K243433.

What company makes enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System?

enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System is manufactured by STERIS Corporation.

What is the FDA product code for enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System?

The FDA product code for enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System is FEB.

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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 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: FEB)

K162128Scope Buddy Plus Endoscope Flushing AidMedivators, Inc. K152189EVOTECH ECRAdvanced Sterilization Products (Asp) K172677Advantage Plus Pass-ThruMedivators, Inc. K162120Scope-Assist Flushing SinkCustom Ultrasonics, Inc. K181865Acu-sInQ Complete Endoscope Cleaning Aid SystemSTERIS Corporation K190969ENDOSCOPE REPROCESSOR OER-EliteOlympus Medical Systems Corp.

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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