FDA 510(k)

单次使用吸引-排空式输尿管通道鞘

K号: K250128 · 2025-09-19

申请人Anhui Happiness Workshop Medical Instruments Co., Ltd.

决定日期2025-09-19

产品代码FED

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决定实质等同

器械摘要

Single Use Suction-Evacuation Ureteral Access Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Anhui Happiness Workshop Medical Instruments Co., Ltd.. It received FDA 510(k) clearance on 2025-09-19 under 510(k) number K250128. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

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. The listed applicant is Anhui Happiness Workshop Medical Instruments Co., Ltd.. The 510(k) number is K250128.

When did Single Use Suction-Evacuation Ureteral Access Sheath receive FDA 510(k) clearance?

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

Who is the listed applicant for Single Use Suction-Evacuation Ureteral Access Sheath?

The FDA 510(k) record lists Anhui Happiness Workshop Medical Instruments Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

官方来源

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单次使用吸引-排空式输尿管通道鞘

器械摘要

常见问题

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官方来源