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FDA 510(k)

enspire 300 Series Automated Endoscope Reprocessor System

K-Number: K230560 · 2023-07-21

ApplicantSTERIS Corporation
Decision Date2023-07-21
Product CodeNZA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

enspire 300 Series Automated Endoscope Reprocessor System is a medical device manufactured by STERIS Corporation. It received FDA 510(k) clearance on 2023-07-21 under approval number K230560. The device is classified under product code NZA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the enspire 300 Series Automated Endoscope Reprocessor System?

enspire 300 Series Automated Endoscope Reprocessor System is a medical device that received FDA 510(k) clearance on 2023-07-21. It is manufactured by STERIS Corporation. The 510(k) number is K230560.

When was enspire 300 Series Automated Endoscope Reprocessor System approved by the FDA?

enspire 300 Series Automated Endoscope Reprocessor System received FDA 510(k) clearance on 2023-07-21, under approval number K230560.

What company makes enspire 300 Series Automated Endoscope Reprocessor System?

enspire 300 Series Automated Endoscope Reprocessor System is manufactured by STERIS Corporation.

What is the FDA product code for enspire 300 Series Automated Endoscope Reprocessor System?

The FDA product code for enspire 300 Series Automated Endoscope Reprocessor System is NZA.

Related Clinical Trials

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Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026) PMID: 41251011 Effectivity of the Dehydrated Human Amnion/Chorion Membrane Allograft for Diabetic Foot Ulcers in Japan: A Case Series. International wound journal (2025)

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Related Devices (Code: NZA)

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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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