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FDA 510(k)

enspire 3000 Cleaning and Liquid Chemical Sterile Processing System

K-Number: K230930 · 2023-06-30

ApplicantSTERIS Corporation
Decision Date2023-06-30
Product CodeFEB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

enspire 3000 Cleaning and Liquid Chemical Sterile Processing System is the device name listed in this FDA 510(k) record. The listed applicant is STERIS Corporation. It received FDA 510(k) clearance on 2023-06-30 under 510(k) number K230930. 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 Sterile Processing System?

enspire 3000 Cleaning and Liquid Chemical Sterile Processing System is a medical device that received FDA 510(k) clearance on 2023-06-30. The listed applicant is STERIS Corporation. The 510(k) number is K230930.

When did enspire 3000 Cleaning and Liquid Chemical Sterile Processing System receive FDA 510(k) clearance?

enspire 3000 Cleaning and Liquid Chemical Sterile Processing System received FDA 510(k) clearance on 2023-06-30, under 510(k) number K230930.

Who is the listed applicant for enspire 3000 Cleaning and Liquid Chemical Sterile Processing System?

The FDA 510(k) record lists STERIS Corporation as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing STERIS Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261055AMSCO 700 Steam SterilizerK260766Celerity 5 HP Biological Indicator (LCB052)K251666SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900K252680Celerity™ 20 HP Biological IndicatorK251452Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)K251048Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118

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Related Devices (Code: FEB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241168System 83 Revolve Endoscope Washer/DisinfectorWassenburg Medical, Inc.K243433enspire 3000 Cleaning and Liquid Chemical Sterilant Processing SystemSTERIS CorporationK213833SCOPE BUDDY PLUS Endoscope Flushing AidMedivators, Inc.K201920Endoscope Reprocessor OER-EliteOlympus Medical Systems Corp.K173590System 83 Plus Washer/DisinfectorCustom Ultrasonics, Inc.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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