FDA 510(k)

Disposable ureteral access sheath

Número K: K243710 · 2025-04-11

RequerenteShenzhen Trious Medical Technology Co., Ltd.

Data da decisão2025-04-11

Código do produtoFED

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Disposable ureteral access sheath is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Trious Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-04-11 under 510(k) number K243710. 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 Disposable ureteral access sheath?

Disposable ureteral access sheath is a medical device that received FDA 510(k) clearance on 2025-04-11. The listed applicant is Shenzhen Trious Medical Technology Co., Ltd.. The 510(k) number is K243710.

When did Disposable ureteral access sheath receive FDA 510(k) clearance?

Disposable ureteral access sheath received FDA 510(k) clearance on 2025-04-11, under 510(k) number K243710.

Who is the listed applicant for Disposable ureteral access sheath?

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

What is the FDA product code for Disposable ureteral access sheath?

The FDA product code for Disposable ureteral access sheath is FED.

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Outros registros que listam Shenzhen Trious Medical Technology Co., Ltd. como candidato(a)

K250448Disposable Percutaneous Nephrostomy Dilatation Kit K243830Disposable ureteral stent

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.

Fonte oficial

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