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FDA 510(k)

BioGuard Air/Water and Suction Valves

K-Number: K203630 · 2021-01-08

ApplicantSteris Corporations
Decision Date2021-01-08
Product CodeODC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BioGuard Air/Water and Suction Valves is the device name listed in this FDA 510(k) record. The listed applicant is Steris Corporations. It received FDA 510(k) clearance on 2021-01-08 under 510(k) number K203630. 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 Air/Water and Suction Valves?

BioGuard Air/Water and Suction Valves is a medical device that received FDA 510(k) clearance on 2021-01-08. The listed applicant is Steris Corporations. The 510(k) number is K203630.

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

BioGuard Air/Water and Suction Valves received FDA 510(k) clearance on 2021-01-08, under 510(k) number K203630.

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

The FDA 510(k) record lists Steris Corporations as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for BioGuard Air/Water and Suction Valves is ODC.

Other records listing Steris Corporations as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: ODC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252933DYNE PORTDyne Medical Group, Inc.K250145Biopsy Port AdapterEndosound, Inc.K252910Orca Air/Water and Suction ValvesBoston ScientificK250949Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)Olympus Medical Systems CorporationK250732Disposable Endoscopy Valve SetYangzhou Fartley Medical Instrument Technology Co., Ltd.K241842Luer-Split MAJ-2092Olympus Medical Systems Corporation

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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