FDA 510(k)

Single Use Suction-Evacuation Ureteral Access Sheath

Номер K: K250128 · 2025-09-19

ЗаявительAnhui Happiness Workshop Medical Instruments Co., Ltd.

Дата решения2025-09-19

Код продуктаFED

Консультативный комитетGU

РешениеSubstantially Equivalent

Описание устройства

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.

Часто задаваемые вопросы

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: FED)

K260512Disposable Ureteral Access SheathYangzhou Fartley Medical Instrument Technology Co., Ltd.K262262Pathfinder Endoscope OvertubeNeptune Medical, Inc.K260410Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., Ltd.K261915Navigator™ Flex Ureteral Access Sheath SetBoston Scientific Corporation K260965CVAC Aspiration SystemCalyxo, Inc.K260521ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)Zhuhai Pusen Medical Technology Co., Ltd.

Официальный источник

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