FDA 510(k)

enspire 300 Series Automated Endoscope Reprocessor System

K-Number: K230560 · 2023-07-21

Decision Date2023-07-21

Product CodeNZA

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

enspire 300 Series Automated Endoscope Reprocessor 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 2023-07-21 under 510(k) 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. The listed applicant is STERIS Corporation. The 510(k) number is K230560.

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

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

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

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

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Related Devices (Code: NZA)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.