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FDA 510(k)

enspire 300 Series Automated Endoscope Reprocessor

K-Number: K232918 · 2023-10-03

ApplicantSTERIS Corporation
Decision Date2023-10-03
Product CodeNZA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

enspire 300 Series Automated Endoscope Reprocessor is the device name listed in this FDA 510(k) record. The listed applicant is STERIS Corporation. It received FDA 510(k) clearance on 2023-10-03 under 510(k) number K232918. 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?

enspire 300 Series Automated Endoscope Reprocessor is a medical device that received FDA 510(k) clearance on 2023-10-03. The listed applicant is STERIS Corporation. The 510(k) number is K232918.

When did enspire 300 Series Automated Endoscope Reprocessor receive FDA 510(k) clearance?

enspire 300 Series Automated Endoscope Reprocessor received FDA 510(k) clearance on 2023-10-03, under 510(k) number K232918.

Who is the listed applicant for enspire 300 Series Automated Endoscope Reprocessor?

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 300 Series Automated Endoscope Reprocessor?

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

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Related Devices (Code: NZA)

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.

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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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