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FDA 510(k)

Single Use Ureteral Access Sheath

K-Number: K220065 · 2022-05-25

ApplicantZhejiang Chuangxiang Medical Technology Co., Ltd.
Decision Date2022-05-25
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Single Use Ureteral Access Sheath is a medical device manufactured by Zhejiang Chuangxiang Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-05-25 under approval number K220065. 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 Single Use Ureteral Access Sheath?

Single Use Ureteral Access Sheath is a medical device that received FDA 510(k) clearance on 2022-05-25. It is manufactured by Zhejiang Chuangxiang Medical Technology Co., Ltd.. The 510(k) number is K220065.

When was Single Use Ureteral Access Sheath approved by the FDA?

Single Use Ureteral Access Sheath received FDA 510(k) clearance on 2022-05-25, under approval number K220065.

What company makes Single Use Ureteral Access Sheath?

Single Use Ureteral Access Sheath is manufactured by Zhejiang Chuangxiang Medical Technology Co., Ltd..

What is the FDA product code for Single Use Ureteral Access Sheath?

The FDA product code for Single Use Ureteral Access Sheath is FED.

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Other Devices by Zhejiang Chuangxiang Medical Technology Co., Ltd.

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Related Devices (Code: FED)

K162205Arc EndoCuff and Arc EndoCuff VisionBoddingtons Plastics, Ltd. K161110ClearPetra Suction-Evacuation SheathWell Lead Medical Co., Ltd. K160846AmplifEYEMedivators, Inc. K160861Proxis Ureteral Access SheathC.R. Bard, Inc. K151084Well Lead Ureteral Access SheathWell Lead Medical Co., Ltd. K172217Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access SheathCook Incorporated

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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