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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 a medical device manufactured by STERIS Corporation. It received FDA 510(k) clearance on 2023-10-03 under approval 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. It is manufactured by STERIS Corporation. The 510(k) number is K232918.

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

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

What company makes enspire 300 Series Automated Endoscope Reprocessor?

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

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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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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