FDA 510(k)

Ureteral Access Sheath

Número K: K250132 · 2025-09-05

RequerenteZhejiang YiGao Medical Technology Co., Ltd.

Data da decisão2025-09-05

Código do produtoFED

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Ureteral Access Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang YiGao Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-09-05 under 510(k) number K250132. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Ureteral Access Sheath?

Ureteral Access Sheath is a medical device that received FDA 510(k) clearance on 2025-09-05. The listed applicant is Zhejiang YiGao Medical Technology Co., Ltd.. The 510(k) number is K250132.

When did Ureteral Access Sheath receive FDA 510(k) clearance?

Ureteral Access Sheath received FDA 510(k) clearance on 2025-09-05, under 510(k) number K250132.

Who is the listed applicant for Ureteral Access Sheath?

The FDA 510(k) record lists Zhejiang YiGao Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ureteral Access Sheath?

The FDA product code for Ureteral Access Sheath is FED.

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Dispositivos Relacionados (Código: 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.

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