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FDA 510(k)

BioGuard EUS Air/Water and Suction Valves

K-Number: K202104 · 2021-01-14

ApplicantSTERIS Corporation
Decision Date2021-01-14
Product CodeODC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BioGuard EUS Air/Water and Suction Valves is a medical device manufactured by STERIS Corporation. It received FDA 510(k) clearance on 2021-01-14 under approval number K202104. 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 BioGuard EUS Air/Water and Suction Valves?

BioGuard EUS Air/Water and Suction Valves is a medical device that received FDA 510(k) clearance on 2021-01-14. It is manufactured by STERIS Corporation. The 510(k) number is K202104.

When was BioGuard EUS Air/Water and Suction Valves approved by the FDA?

BioGuard EUS Air/Water and Suction Valves received FDA 510(k) clearance on 2021-01-14, under approval number K202104.

What company makes BioGuard EUS Air/Water and Suction Valves?

BioGuard EUS Air/Water and Suction Valves is manufactured by STERIS Corporation.

What is the FDA product code for BioGuard EUS Air/Water and Suction Valves?

The FDA product code for BioGuard EUS Air/Water and Suction Valves 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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