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FDA 510(k)

Disposable Ureteral Access Sheath

K-Number: K203165 · 2021-04-30

ApplicantSuzhou Beyo Medical Technology Co., Ltd.
Decision Date2021-04-30
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Disposable Ureteral Access Sheath is a medical device manufactured by Suzhou Beyo Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-04-30 under approval number K203165. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Disposable Ureteral Access Sheath?

Disposable Ureteral Access Sheath is a medical device that received FDA 510(k) clearance on 2021-04-30. It is manufactured by Suzhou Beyo Medical Technology Co., Ltd.. The 510(k) number is K203165.

When was Disposable Ureteral Access Sheath approved by the FDA?

Disposable Ureteral Access Sheath received FDA 510(k) clearance on 2021-04-30, under approval number K203165.

What company makes Disposable Ureteral Access Sheath?

Disposable Ureteral Access Sheath is manufactured by Suzhou Beyo Medical Technology Co., Ltd..

What is the FDA product code for Disposable Ureteral Access Sheath?

The FDA product code for Disposable Ureteral Access Sheath is FED.

Related Clinical Trials

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Related Devices (Code: FED)

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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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