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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 the device name listed in this FDA 510(k) record. The listed applicant is STERIS Corporation. It received FDA 510(k) clearance on 2021-01-14 under 510(k) 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. The listed applicant is STERIS Corporation. The 510(k) number is K202104.

When did BioGuard EUS Air/Water and Suction Valves receive FDA 510(k) clearance?

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

Who is the listed applicant for BioGuard EUS Air/Water and Suction Valves?

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 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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