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FDA 510(k)

Single Use Suction-Evacuation Ureteral Access Sheath

K-Number: K250128 · 2025-09-19

ApplicantAnhui Happiness Workshop Medical Instruments Co., Ltd.
Decision Date2025-09-19
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Single Use Suction-Evacuation Ureteral Access Sheath is a medical device manufactured by Anhui Happiness Workshop Medical Instruments Co., Ltd.. It received FDA 510(k) clearance on 2025-09-19 under approval number K250128. 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 Suction-Evacuation Ureteral Access Sheath?

Single Use Suction-Evacuation Ureteral Access Sheath is a medical device that received FDA 510(k) clearance on 2025-09-19. It is manufactured by Anhui Happiness Workshop Medical Instruments Co., Ltd.. The 510(k) number is K250128.

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

Single Use Suction-Evacuation Ureteral Access Sheath received FDA 510(k) clearance on 2025-09-19, under approval number K250128.

What company makes Single Use Suction-Evacuation Ureteral Access Sheath?

Single Use Suction-Evacuation Ureteral Access Sheath is manufactured by Anhui Happiness Workshop Medical Instruments Co., Ltd..

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

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

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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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