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FDA 510(k)

DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)

K-Number: K240098 · 2024-02-09

ApplicantSTERIS Corporation
Decision Date2024-02-09
Product CodeODC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) is the device name listed in this FDA 510(k) record. The listed applicant is STERIS Corporation. It received FDA 510(k) clearance on 2024-02-09 under 510(k) number K240098. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)?

DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) is a medical device that received FDA 510(k) clearance on 2024-02-09. The listed applicant is STERIS Corporation. The 510(k) number is K240098.

When did DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) receive FDA 510(k) clearance?

DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) received FDA 510(k) clearance on 2024-02-09, under 510(k) number K240098.

Who is the listed applicant for DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)?

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 DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)?

The FDA product code for DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) is ODC.

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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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